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Background: Current guidance suggests oral antibiotics can be considered for children with acute otitis media (AOM) and ear discharge, but there is an absence of evidence regarding the relative effectiveness of antibiotic-corticosteroid eardrops., Aim: To establish whether antibiotic-corticosteroid eardrops are non-inferior to oral antibiotics in children with AOM and ear discharge., Design and Setting: Open randomized controlled non-inferiority trial set in Dutch primary care., Methods: Children were randomized to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin suspension (50 mg per kilogram of body weight per day, divided over three doses administered orally) for 7 days. The primary outcome was the proportion of children with resolution of ear pain and fever at day 3., Results: Between December 2017 and March 2023, 58 of the planned 350 children were recruited due to slow accrual for various reasons. Children assigned to eardrops (n = 26) had lower resolution rates of ear pain and fever at 3 days compared to those receiving oral antibiotics (n = 31): 42% vs 65%; adjusted risk difference 20.3%, 95% confidence interval -5.3% to 41.9%), longer parent-reported ear discharge (6 vs 3 days; P = .04), and slightly higher mean ear pain scores (Likert scale 0-6) over days 1-3 (2.1 vs 1.4, P = .02), but received fewer oral antibiotic courses in 3months (11 for 25 children vs 33 for 30 children), and had less GI upset and rash (12% vs 32% and 8% vs 16%, respectively)., Conclusion: Early termination stopped us from determining non-inferiority of antibiotic-corticosteroid eardrops. Our limited data, requiring confirmation, suggest that oral antibiotics may be more effective than antibiotic-corticosteroid eardrops in resolving symptoms and shortening the duration of ear discharge., (© The Author(s) 2024. Published by Oxford University Press.)

Background: Acute otitis media (AOM) is the most common reason children are prescribed antibiotics. Bacteria that produce beta-lactamase are an increasingly frequent cause of AOM and may be resistant to amoxicillin, the currently recommended treatment for AOM. We aimed to evaluate the clinical outcomes of children treated with amoxicillin for AOM and assessed whether outcomes vary by infecting pathogen or beta-lactamase production., Methods: 205 children 6-35 months old diagnosed with AOM and prescribed amoxicillin were included. Bacterial culture and qualitative multiplex real-time polymerase chain reaction were performed on nasopharyngeal swabs collected at enrollment. Parents completed surveys assessing symptoms, antibiotic adherence, and potential adverse events. The primary outcome was treatment failure with amoxicillin. Secondary outcomes included recurrence, symptom improvement, resolution, and adverse drug events (ADE)., Results: 8 children (5.4%) experienced treatment failure and 14 (6.8%) had recurrence. By day 5, 152 (74.1%) children had symptom improvement and 97 (47.3%) had resolution. Parents reported ADE for 56 (27.3%) children. Among 149 children who did not take any amoxicillin before enrollment, 98 (65.8%) had one or more beta-lactamase-producing bacteria. Common bacterial otopathogens were Moraxella catarrhalis (79, 53.0%), Streptococcus pneumoniae (51, 34.2%), Haemophilus influenzae (30, 20.1%), and Staphylococcus aureus (21, 14.1%). Treatment failure did not differ between children that did (5, 5.1%) and did not (3, 5.9%) have beta-lactamase-producing otopathogens (p = .05)., Conclusions: Among children diagnosed with AOM treated with amoxicillin, treatment failure was uncommon and did not differ by pathogen or beta-lactamase production. These data support guidance recommending amoxicillin despite an increasing prevalence of beta-lactamase-producing bacteria., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Update of the consensus on acute otitis media (AOM) (2012) and sinusitis (2013) following the introduction of pneumococcal vaccines in the immunization schedule, and related changes, such as epidemiological variation, colonization by of nonvaccine serotypes and emerging antimicrobial resistances. A majority of studies show that the introduction of the pneumococcal 13-valent conjugate vaccine has been followed by a reduction in the nasopharyngeal carriage of pneumococcus, with an increase in the proportion of drug-resistant nonvaccine serotypes. The diagnosis of AOM is still clinical, although more stringent criteria are proposed, which are based on the visualization of abnormalities in the tympanic membrane and the findings of pneumatic otoscopy performed by trained clinicians. The routine diagnosis of sinusitis is also clinical, and the use of imaging is restricted to the assessment of complications. Analgesia with acetaminophen or ibuprofen is the cornerstone of AOM management; watchful waiting or delayed antibiotic prescription may be suitable strategies in select patients. The first-line antibiotic drug in children with AOM and sinusitis and moderate to severe disease is still high-dose amoxicillin, or amoxicillin-clavulanic acid in select cases. Short-course regimens lasting 5-7 days are recommended for patients with uncomplicated disease, no risk factors and a mild presentation. In allergic patients, the selection of the antibiotic agent must be individualized based on severity and whether or not the allergy is IgE-mediated. In recurrent AOM, the choice between watchful waiting, antibiotic prophylaxis or surgery must be individualized based on the clinical characteristics of the patient., (Copyright © 2023 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.)

Acute otitis media (AOM) in children is one of the leading causes of health care visits and antibiotic prescriptions worldwide. The overall aim of the current study is twofold: 1. to analyze and discuss the antibiotic prescription patterns in AOM in children without complications or risk factors and 2. to assess to what extent the watchful-waiting approach is a real practice or a mere desideratum. We performed an electronic search in the PubMed and Embase databases from 2013 to 2023 to capture original research studies investigating antibiotic prescribing patterns for AOM in children. Among the 12 papers included in the analysis, the antibiotic prescription rate ranged from 44.8% to 98%. Our study reveals similarities regarding the use of amoxicillin as a first-line antibiotic in pediatric AOM, but also discrepancies in the watchful-waiting approach attitude and in the choice of second or third-line antimicrobial agents. The proportion of cases managed with the watchful-waiting approach ranged from 7.5% (Australia) to 55.2% (Finland). Denmark was the only country reporting penicillin V as a first-choice regimen for children with AOM, which fulfils the guidelines' recommendations. The most unsatisfying rate of amoxicillin use was recorded in Japan, contrary to the recommendations of local guidelines. The use of quinolones was reported in two out of twelve studies, with the highest proportion in Japan, where tosufloxacin was used in 21.4% of the total number of cases. The duration of the antibiotic regimens was analyzed in three out of twelve papers. Since global antibiotic overuse contributes to the emergence of antibiotic resistant bacteria, new strategies are needed to increase the rate of watchful waiting and to promote the judicious use of antibiotics.

Background: Acute otitis media (AOM) is the inflammation of the middle ear. It constitutes one of the most frequent infections which affects children and usually occurs between 6 to 24 months of age. AOM can emerge due to viruses and/or bacteria. The aim of the current systematic review is to assess in children between 6 months and 12 years of age with AOM, the efficacy of any antimicrobial agent or placebo compared with amoxicillinclavulanate, to measure the resolution of AOM or symptoms., Methods: The medical databases PubMed (MEDLINE) and Web of Science were used. Data extraction and analysis were performed by two independent reviewers. Eligibility criteria were set, and only randomised control trials (RCTs) were included. Critical appraisal of the eligible studies was performed. Pooled analysis was conducted using the Review Manager v. 5.4.1 software (RevMan)., Results: Twelve RCTs were totally included. Three (25.0%) RCTs studied the impact of azithromycin, two (16.7%) investigated the impact of cefdinir, two (16.7%) investigated placebo, three (25.0%) studied quinolones, one (8.3%) investigated cefaclor and one (8.3%) studied penicillin V, compared to amoxicillin-clavulanate. In five (41.7%) RCTs, amoxicillin-clavulanate proved to be superior to azithromycin, cefdinir, placebo, cefaclor and penicillin V, while in seven (58.3%) RCTs its efficacy was comparable with other antimicrobials or placebo. The rates of AOM relapse after treatment with amoxicillin-clavulanate were comparable to those of other antimicrobials or placebo. However, amoxicillin-clavulanate was more effective in eradicating Streptococcus pneumoniae from the culture, when compared to cefdinir. The results of the meta-analysis were not evaluated due to substantial heterogeneity between studies., Conclusions: Amoxicillin-clavulanate should be the treatment of choice for children between 6 months and 12 years of age with AOM.

Objectives: The objective of the study was to compare the antibiotic treatment failure and recurrence rates between antibiotic agents (amoxicillin, amoxicillin-clavulanate, cefdinir, and azithromycin) for children with uncomplicated acute otitis media (AOM)., Study Design: We completed a retrospective cohort study of children 6 months-12 years of age with uncomplicated AOM identified in a nationwide claims database. The primary exposure was the antibiotic agent, and the primary outcomes were treatment failure and recurrence. Logistic regression was used to estimate ORs, and analyses were stratified by primary exposure, patient age, and antibiotic duration., Results: Among the 1 051 007 children included in the analysis, 56.6% were prescribed amoxicillin, 13.5% were prescribed amoxicillin-clavulanate, 20.6% were prescribed cefdinir, and 9.3% were prescribed azithromycin. Most prescriptions (93%) were for 10 days, and 98% were filled within 1 day of the medical encounter. Treatment failure and recurrence occurred in 2.2% (95% CI: 2.1, 2.2) and 3.3% (3.2, 3.3) of children, respectively. Combined failure and recurrence rates were low for all agents including amoxicillin (1.7%; 1.7, 1.8), amoxicillin-clavulanate (11.3%; 11.1, 11.5), cefdinir (10.0%; 9.8, 10.1), and azithromycin (9.8%; 9.6, 10.0)., Conclusions: Despite microbiologic changes in AOM etiology, treatment failure and recurrence were uncommon for all antibiotic agents and were lower for amoxicillin than for other agents. These findings support the continued use of amoxicillin as a first-line agent for AOM when antibiotics are prescribed., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To identify risk factors associated with acute otitis media treatment failure (AOMTF) among 13-valent pneumococcal conjugate vaccine (PCV) immunized children., Methods: In this retrospective study, we identified children <12 years who were admitted to our hospital November 2017-October 2020. Children were categorized either as acute otitis media treatment failure (AOMTF), if they received adequate pre-admission antibiotics, or as AOM without treatment failure (AOMwTF), if they did not receive any pre-admission antibiotics. We collected demographics, clinical behavior, laboratory results, length and hospitalization course. Hospitalization was justified if previously treated properly., Results: The AOMTF group included 84 children (43 boys, mean age: 1.30 ± 0.83 years), whereas the AOMwTF group included 251 children (132 boys, mean age: 1.20 ± 0.89 years). AOMTF accounted for 25% of all AOM admissions. Among the AOMTF group, 46 (54.8%) were treated with amoxicillin and 24 (28.6%) with amoxicillin/clavulanic acid. Risk factors for AOMTF included recurrent AOM episodes history (30.9% vs 5.5%, OR 7.6, 95%CI 3.5-15.4, p < 0.001), otorrhea (29.4% vs 9.5%, OR 4, 95%CI 2.1-7.5, p < 0.001), tympanic membrane perforation (14.2% vs 4.3%, OR 3.6, 95%CI 1.5-8.6, p < 0.0019). Children with AOMTF were treated more with 2nd- or 3rd-line antibiotics (90.2% vs 65.9%, OR 4, 95%CI 2.2-10.4, p < 0.001), and underwent more myringotomy/ventilation tube insertions (14.4% vs 6.9%, OR 2.3, 95%CI 1.0-5.0, p = 0.037). Mean admission durations were similar: 3.83 ± 1.6 days in the AOMTF group vs 3.37 ± 2.77 days in the AOMwTF group (p = 0.15)., Conclusion: Risk factors associated with AOMTF should be identified early during the AOM course to reduce complication rates and surgery referral., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background and Objectives: Acute otitis media (AOM) is one of the most frequent causes of consultation and antibiotic prescription in pediatrics. The objective of this work is to evaluate the practice of delayed antibiotic prescription in AOM in pediatrics in primary care., Material and Methods: Observational, retrospective study, through reviewing of medical records in a Primary Care Center of Aragon Community of children with OMA in which doctors perform delayed prescription. Logistic regression analyzes possibly related to antibiotic prescription factors., Results: 1390 episodes of AOM are analyzed in 696 patients. Immediate antibiotic prescription is performed in 67.6% (95% CI: 65.1-70.0%) of episodes, exclusive symptomatic in 13.7% (IC 95: 11.9-15.6%), and delayed antibiotic in 18.7% (IC 95: 16.7%-20.8%), finally being given in 53.5% (IC 95: 47.4-59.5%) of these. Factors significantly related to final antimicrobial dispensation in delayed prescription are aged between 0 and 2 years (OR 1.89, 95% CI: 1.25-2.87), bilaterality (OR 2.54, 95% CI: 1.48-4.35), ear pain (OR 0.49, CI 95: 0.29-0.82), fever (OR 2.67, IC 95: 1.95-3.65), bulging (OR 3,63; IC 95: 2,50-5,29) and otorrhea (OR 25.98; IC 95: 12.75-52.92). The same factors have influence on global prescription of antibiotics. Amoxicillin (74.6%) is the most indicated antibiotic, followed by Amoxicillin-Clavulanic (17.0%)., Conclusions: Delayed prescription in AOM seems to be useful to reduce antibiotics consumption, being necessary to advance in its implantation., (Copyright © 2022. Published by Elsevier España, S.L.U.)

Public interventions have shown to optimize the use of antibiotics in children with acute otitis media (AOM). In this study, we describe the AOM-related antibiotic use among children in South Korea using national cohort data. We retrieved the Health Insurance Review & Assessment Service data to construct a national cohort of children aged 0-6 years who had been diagnosed with AOM between 2012 and 2018. Of 25,212,264 children included, the antibiotic prescription has increased for amoxicillin/amoxicillin-clavulanate from 56.1% in 2012 to 61.8% in 2018. Prescription has decreased for cephalosporin (35.1% in 2012 to 31.8% in 2018) and macrolide (8.7% in 2012 to 6.4% in 2018). National cohort data have shown an increased trend in AOM-related aminopenicillin prescription and downward trend cephalosporin and macrolide use in South Korea. A multi-faceted approach is required to control the antimicrobial resistance at a population level., Competing Interests: The authors have no potential conflicts of interest to disclose., (© 2021 The Korean Academy of Medical Sciences.)

Introduction: Acute otitis media is a highly prevalent disease in children. Although guidelines in many countries recommend amoxicillin as the first-line treatment for acute otitis media, the prescribing pattern in Japan is not clear. Our objective was to clarify the amoxicillin prescriptions as first-line antibiotics for acute otitis media and factors associated with amoxicillin prescriptions. Also, changes in amoxicillin prescriptions during the study period by medical facilities were investigated., Methods: Using an administrative claims database, we included new episodes of acute otitis media prescribed antibiotics in children under seven years of age between 2014 and 2018. The proportion of amoxicillin prescription was described. Using multivariate logistic regression analysis, factors associated with amoxicillin prescription were evaluated. Rate differences were calculated to describe changes in amoxicillin prescription by medical facilities., Results: 207,213 episodes in 149,929 patients were identified. Amoxicillin prescription was 24.0% and increased over the study period (P for trend <0.001). Characteristics of medical facilities were associated with amoxicillin prescriptions, and hospitals were more likely to prescribe amoxicillin (adjusted odds ratio: 1.71, 95% confidence intervals: 1.63 to 1.79). Compared to 2014, the range of increase in amoxicillin prescription in 2018 was greater in hospitals (14.9%) and pediatric clinics (10.5%) than in otolaryngology clinics (5.9%) and other specialty clinics (6.0%)., Conclusions: During the study period, amoxicillin prescriptions had increased compared to 2014, but the proportion was still low. Clinics prescribed less amoxicillin than hospitals, and the range of increase was small. Our results suggested that some interventions focused on clinics are needed., (Copyright © 2021 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Antibiotic-associated diarrhea (AAD) is a typical side effect of antibiotic treatment, especially in children. Amoxicillin (AMPC) and amoxicillin/clavulanate (AMPC/CVA) are associated with high risk of AAD; however, these antibiotics are important in the pediatric field. Recent research suggests that probiotics prevent pediatric AAD, including that caused by AMPC and AMPC/CVA. Indeed, guidelines for acute otitis media in children recommend the concomitant use of probiotics. However, the prescription status of probiotics for pediatric patients with otitis media receiving oral AMPC and AMPC/CVA remains unknown. We therefore conducted a survey to clarify the current status of these prescriptions and, in particular, to identify specific populations with a low proportion of probiotic prescriptions. Pediatric patients (≤15 years of age) newly prescribed oral AMPC or AMPC/CVA for otitis media between April 2016 and March 2017 were identified from a Japanese health insurance claims database. Eligible patients were divided into the AMPC (1303 patients) and AMPC/CVA (424 patients) groups, in which 659 (50.6%) and 293 (69.1%) patients were prescribed probiotics, respectively. Of the patients receiving probiotic prescriptions in the AMPC and AMPC/CVA groups, 632 (95.9%) and 286 (97.6%) patients received antibiotic-resistant probiotic prescriptions, respectively. When classified by the prescribing clinical department and patient age, the proportions of probiotic prescriptions in Internal Medicine and Pediatrics departments were lower than those in the Otorhinolaryngology department regardless of age. These results indicate the probability of insufficient probiotic prescriptions for pediatric patients with otitis media. Solving this issue may lead to the provision of safer antimicrobial therapy.

Objectives: To facilitate better antibiotic stewardship, we conducted this clinical trial to identify the prognostic features of treatment failure in pediatric acute otitis media (AOM)., Study: Design: This is a randomized, parallel-group, open-label, comparative clinical trial., Subjects and Methods: Children with AOM and aged between 1 month and 5 years were enrolled. Patients were randomly assigned to receive either amoxicillin alone (70 mg/kg) for five days, or the same with additional clarithromycin (15 mg/kg) for the initial three days. The clinical course of AOM was evaluated based on tympanic membrane scores. Failure of treatment for AOM was confirmed on day 14. Nasal conditions were also assessed by a clinical scoring system for acute rhinosinusitis., Results: Treatment failures occurred in 25 out of 129 (19.4%) children. The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years. The tympanic membrane scores on day 3 (P = 0.0334) and day 5 (P < 0.0001) and acute rhinosinusitis scores on day 5 (P = 0.0004) were higher in failure cases than in cured cases. Multivariate logistic regression analysis indicated significant associations between the treatment failure with tympanic membrane scores and acute rhinosinusitis scores on day 5, and the antimicrobial treatment regimen., Conclusions: Improvement of acute rhinosinusitis and tympanic membrane scores on day five were important predictive features in failure of treatment for pediatric AOM. These results will be useful when discussing the treatment decisions with the patient's parents., (Copyright © 2020 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Objective: To evaluate, by applying pharmacokinetic/pharmacodynamic (PK/PD) analysis, if the change in antibiotic susceptibility after the introduction of the 7-valent pneumococcal conjugate vaccine (PCV7) in Spain had any influence on the usefulness of the antimicrobials more frequently used as empirical treatment of pediatric acute otitis media (AOM)., Methods: PK parameters and susceptibility of Streptococcus pneumoniae and Haemophilus influenzae were obtained from bibliography. Monte Carlo simulation was used to estimate the cumulative fraction of response (CFR), understood as the expected probability of therapy success. For amoxicillin and amoxicillin/clavulanate, the target was free antibiotic concentration remaining above the minimum inhibitory concentration (MIC) for ≥50% of the dosing interval (fT>MIC≥50%), whereas for cefuroxime axetil and cefotaxime, the target was fT>MIC≥60%. CFR values ≥90% were considered successful., Results: When all serotypes of S. pneumoniae are considered, amoxicillin and cefotaxime turned out to reach a high probability of success, and difference before and after vaccination was scarce. For H. influenzae, CFR values were higher with amoxicillin/clavulanate than with amoxicillin. For both microorganisms, cefuroxime axetil resulted in low probability of success in the two periods of study., Conclusions: We have shown that the introduction of the PCV7 vaccination did not lead to changes in the probability of success of the current empiric treatments of the AOM. Integrated PK/PD analysis has demonstrated to be a useful tool to identify changes in antimicrobial activity after the implantation of a vaccination program, providing complementary information to the simple assessment of MIC values., (©The Author 2019. Published by Sociedad Española de Quimioterapia. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)(https://creativecommons.org/licenses/by-nc/4.0/).)

Background: Despite concerns that antimicrobial treatment of prevalent infections may select for drug-resistant bacteria, the effects of antimicrobial treatment on colonization dynamics have not been well quantified., Methods: We measured impacts of antimicrobial treatment on nasopharyngeal carriage of penicillin-susceptible Streptococcus pneumoniae (PSSP) and penicillin-nonsusceptible (PNSP) lineages at the end of treatment and 15, 30, and 60 days after treatment in a previously conducted randomized, double-blinded, placebo-controlled trial of amoxicillin-clavulanate for stringently defined acute otitis media., Results: In intention-to-treat analyses, immediate treatment with amoxicillin-clavulanate reduced PSSP carriage prevalence by 88% (95% confidence interval [CI], 76%-96%) at the end of treatment and by 27% (-3%-49%) after 60 days but did not alter PNSP carriage prevalence. By the end of treatment, 7% of children who carried PSSP at enrollment remained colonized in the amoxicillin-clavulanate arm, compared with 61% of PSSP carriers who received placebo; impacts of amoxicillin-clavulanate persisted at least 60 days after treatment among children who carried PSSP at enrollment. Amoxicillin-clavulanate therapy reduced PSSP acquisition by >80% over 15 days. Among children who carried PNSP at enrollment, no impacts on carriage prevalence of S. pneumoniae, PSSP, or PNSP were evident at follow-up visits., Conclusions: Although the absolute risk of carrying PNSP was unaffected by treatment, antimicrobial therapy conferred a selective impact on colonizing pneumococci by accelerating clearance and delaying acquisition of PSSP.

Introduction: Amoxicillin is the first-line antibiotic recommended by most scientific societies for the treatment of uncomplicated acute otitis media (AOM) in children and adults. In low-income and middle-income countries however, absence of setting-specific recommendations and antibiotic resistance, promoted by higher population density and over-the-counter antibiotic availability, could hamper the effectiveness of amoxicillin. We aim to provide updated information to enable evidence-based decisions for first-line therapy of uncomplicated AOM in our setting., Methods and Analysis: We will conduct a systematic review of all randomised controlled trials on the clinical effectiveness of amoxicillin for the treatment of uncomplicated AOM in children above 6 months and adults. The search will include studies published from the generation of the included databases to 31 December 2017. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and study quality will be assessed by the Risk of Bias Assessment Tool from the Cochrane Handbook for randomised trials. A meta-analysis will be conducted for homogeneous studies, eventually, using the fixed-effect model. Subgroup analysis will include age groups, amoxicillin dosage, treatment duration, effectiveness criteria, time of trial realisation, study quality and region of the world involved., Ethics and Dissemination: Formal ethical approval is not required, as primary data will not be collected. The results will be disseminated through a peer-reviewed publication and presented at scientific meetings., Prospero Registration Number: CRD42017080029., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Over-treatment of acute otitis media (AOM) with antibiotics is common, and poses a high burden on health-care systems., Methods: Records of children 6-36 months of age with AOM visiting a university-affiliated pediatric emergency department between 2014 and 2016 were reviewed for the treatment given: watchful waiting versus antibiotics. If antibiotics were prescribed, the type and duration were recorded. We evaluated appropriate and inappropriate treatment rates of eligible AOM cases, in respect to the local guidelines, which encourage watchful waiting in most mild-moderate cases., Results: Out of 1493 AOM visits, 863 (57.8%) were boys, with a median age of 14.9 months (interquartile range, 9-19). The overall pre-visit antibiotic rate was 24.1%, but among those children examined by a physician, this rate was 95.2%. Amoxicillin was the most common antibiotic, administered in 66.3% of the cases. Only 21 children (5.8%) had been treated with antibiotics for ≥7 days before their visit, and were considered as treatment failure. Antibiotic therapy upon discharge was recorded in 1394/1449 visits (96.2%), again with amoxicillin as the most common antibiotic therapy, in 80.8% of the cases. In these visits, the average duration of antibiotic treatment was 8.29 days. Appropriateness of treatment (watchful waiting or antibiotics) could be analyzed in 1134 visits; 20.9% were considered as inappropriate. Of them, 98.3% were prescribed with the wrong antibiotic type and duration., Conclusions: Adherence rate to the local guidelines treatment recommendations for uncomplicated AOM was high, as measured by whether appropriate treatment was given and type and duration of antibiotics.

Acute otitis media (AOM) is very common in early childhood (inferior to 2 years). As a spontaneous recovery occurs in superior to 80 % of cases, antibiotics use should not be systematic. The aim of this review is to discuss AOM diagnostic criteria based on the latest recommendations, aiming a wiser use of antibiotics. Antibiotics use in a child with AOM should take into account the age, the severity of the disease, uni- or bilateral otitis, the presence or absence of otorrhea, and the presence of possible risk factors. Delayed antibiotics prescription might be considered in some specific circumstances. The first line antibiotic treatment is amoxicillin, and increased dosage is efficient in case of resistant pneumococci. Pain evaluation is important, and, in every treatment protocols for AOM, pain-relievers use is needed.

Background: Although there is evidence of an association between antibiotic consumption and resistant bacteria on a population level, the relationship on an individual level has been less well studied, particularly in terms of nasopharyngeal colonization. We have therefore analysed this association, using data from a closely followed cohort of children taking part in a vaccination trial., Methods: 109 children with early onset of acute otitis media (AOM) were randomised to heptavalent pneumococcal conjugate vaccine (PCV7) or no vaccination. They were followed for three years with scheduled appointments as well as sick visits. Nasopharyngeal cultures were obtained at all visits. Antibiotic treatments were recorded, as were risk factors for AOM, including siblings, short breast-feeding and parental smoking. Data were entered into a Cox regression model, and the findings of Streptococcus pneumoniae and Haemophilus influenzae with reduced susceptibility to the penicillin group were related to the number of previous courses of antibiotics., Results: There was evidence of an association between the amount of previously consumed betalactams and colonization with beta-lactamasenegative ampicillin-resistant (BLNAR) H. influenzae (RR 1.21; 95% CI 1.03-1.43; p = 0.03), and also with the most commonly prescribed drug; amoxicillin (RR 1.39; 95% CI 1.09-1.76; p = 0.01). There was no evidence for an association between antibiotic consumption and betalactamase producing H. influenzae or S. pneumoniae with reduced susceptibility to penicillin. Furthermore, there was no evidence of an association between resistant bacteria and AOM risk factors or PCV7., Conclusion: In this subgroup of children, most of whom were given several courses of antibiotics in early childhood, there was evidence of an association between betalactam/amoxicillin consumption and nasopharyngeal colonization with BLNAR strains, bacteria that have increased in prevalence during the last 10-15 years, and that are notoriously difficult to treat with oral antibiotics., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Otitis media is a more frequent occurrence in children, and the disease may progress from an acute to chronic state if appropriate and timely intervention is not initiated., Methods: A total of 212 children aged 6 months to 10 years were examined and treated for otitis media, in a 13-month hospital-based study., Results: Acute otitis media was diagnosed in 130 (61.3 per cent) of the patients. There were 82 (38.7 per cent) chronic suppurative otitis media cases. The incidence of acute otitis media and chronic suppurative otitis media in the first year of life was 54.6 per cent and 45.1 per cent respectively. Chronic suppurative otitis media patients were assigned to one of three treatment groups. Recovery occurred in 70.4 per cent of amoxicillin-treated patients, in 88.9 per cent of amoxicillin-clavulanic acid treated patients and in 96.4 per cent of culture and antibiotic sensitivity test patients. Relapses were seen only in the amoxicillin (five cases) and amoxicillin-clavulanic acid (two cases) groups., Conclusion: The success rate in patients treated with antibiotics makes this option mandatory for an established diagnosis.

Background and Objective: Previous research suggests that physicians may be less likely to diagnose otitis media (OM) and to prescribe broad-spectrum antibiotics for black versus nonblack children. Our objective was to determine whether race is associated with differences in OM diagnosis and antibiotic prescribing nationally., Methods: We examined OM visit rates during 2008 to 2010 for children ≤14 years old using the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. We compared OM visits between black and nonblack children, as percentages of all outpatient visits and visit rates per 1000. We compared antibiotic prescribing by race as the percentage of OM visits receiving narrow-spectrum (eg, amoxicillin) versus broader-spectrum antibiotics. We used multivariable logistic regression to examine whether race was independently associated with antibiotic selection for OM., Results: The percentage of all visits resulting in OM diagnosis was 30% lower in black children compared with others (7% vs 10%, P = .004). However, OM visits per 1000 population were not different between black and nonblack children (253 vs 321, P = .12). When diagnosed with OM during visits in which antibiotics were prescribed, black children were less likely to receive broad-spectrum antibiotics than nonblack children (42% vs 52%, P = .01). In multivariable analysis, black race was negatively associated with broad-spectrum antibiotic prescribing (adjusted odds ratio 0.59; 95% confidence interval, 0.40-0.86)., Conclusions: Differences in treatment choice for black children with OM may indicate race-based differences in physician practice patterns and parental preferences for children with OM., (Copyright © 2014 by the American Academy of Pediatrics.)

To assess the symptoms and signs of acute otitis media and efficiency of simple antibiotics like amoxicillin in its treatment in the primary health care setup. This is a prospective longitudinal study including 204 patients from different institutions. Patients were diagnosed as suffering from acute otitis media when presented with earache, fever, fullness and or otorrhea. Patients were divided into two equal groups on basis of the treatment they received, Group A received only symptomatic treatment while Group B were given Amoxicillin (40 mg/kg/day) for 7 days. Acute otitis media was common in children under 15 years (64.7%). Patients presented with earache (100%), aural fullness (90.68%), fever (76.47%) associated with recent onset of upper respiratory tract infections (88.23%). In group A, improvement was noticed in 28.43% in 3 days while 35.29% in 7 days. In group B, improvement was noticed in 48.03% in day 3 while 86.27% in day 7. In countries where medical care is scarce, patients lost to follow up, it is wise to treat with simple antibiotics like amoxicillin in adequate dose than to treat only symptomatically. It prevents chronicity, early hearing impairments and reduces antibiotic resistance.

We determined the cost of care for 2 diagnosis and management approaches for acute otitis media (AOM) among children 6 to 30 months old. A case-control design was used. Cases included 208 children diagnosed with AOM based on a bulging tympanic membrane (TM) and treated with amoxicillin/clavulanate. Controls (5:1 ratio) included 1020 children with AOM diagnosed not requiring bulging of the TM and treated with amoxicillin. Fewer cases (49%) than controls (69%) were diagnosed with AOM (P < .001), fewer were diagnosed with recurrent AOM or AOM treatment failure (0.34 vs 1.6/child; P < .0001), and fewer had insertion of tympanostomy tubes (6.3% vs 14.8%) due to recurrent AOM (P < .0001). The combined direct payments and indirect costs for management of AOM were $539/case versus $1,023/control. Using Rochester NY payments generalized to the US birth cohort, this case diagnosis and treatment strategy could save $1.008 billion per year., (© The Author(s) 2014.)

Objective: In 2011, new guidelines on antibiotic prescription for acute otitis media (AOM) were published in France to decrease the use of third generation cephalosporins that promote the carriage of extended-spectrum beta-lactamase producing Escherichia coli. Our objective was to assess the impact of the 2011 French recommendations on the type of antibiotics prescribed for AOM., Methods: Fourteen thousand six hundred and sixty-one children, 6 to 24 months of age, presenting with AOM were included in 2 studies, between November 1, 2009 and October 31, 2012. The first one was conducted with the support of 62 private practice pediatricians; the second one was conducted in 7 pediatric emergency departments. Three periods of 1 year each were defined., Results: Antibiotics were prescribed in 12,471 (85.1%) of cases of AOM during the study period. Amoxicillin prescriptions was multiplied by 25, between the first year (2.6%) and the last year (66.1%). Conversely, prescriptions of cefpodoxime proxetil and amoxicillin-clavulanic acid decreased from 33.6% and 62.0% in the first year to 5.2% and 27.7% in the last year, respectively. This trend was observed in both private practices and in the pediatric emergency departments., Conclusion: Amoxicillin became the most frequently prescribed antibiotic for AOM in 2012, complying with the 2011 French guidelines, while the proportion of prescribed broad-spectrum antibiotics decreased. Our study highlights the importance of guidelines to decrease the prescription of broad-spectrum antibiotics, a crucial factor in the prevention of antibiotic resistance., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Objective: This study uses the acute otitis media clinical practice guideline proposed in 2004 as a reference to evaluate whether antibiotics doses that are in line with the recommendations lead to better prognosis. The study also attempts to clarify possible factors that influence the outcome., Study Design: Retrospective cohort study., Subjects and Methods: A total of 400 children with acute otitis media were enrolled. The dosage of amoxicillin was considered to be appropriate when in accord with clinical practice guidelines, that is, 80-90 mg/kg/day. The outcome was defined according to the description of tympanic membrane on medical records. Multivariate logistic regression was used to analyze the relationship between antibiotic dosage and prognosis after adjusting for baseline factors., Results: The majority of prescriptions were under dosage (89.1%) but it was not noticeably associated with outcome (P = 0.41). The correlation between under dosage and poor prognosis was significant in children below 20 kg with bilateral acute otitis media (odds ratio 1.63; 95% CI 1.02-2.59, P = 0.04)., Conclusion: Treating acute otitis media in children, high-dose amoxicillin with clavulanate as recommended in the clinical practice guideline was superior to conventional doses only in children under 20 kg with bilateral diseases.

Amoxicillin is a first-line antibiotic treatment for acute otitis media in children and one of the most commonly used antibiotics for human bacterial infections. We investigated changes in salivary bacterial communities among children treated with amoxicillin for acute otitis media (n = 18), using a culture-independent approach based on pyrosequencing of the V3 region of the bacterial 16S rRNA gene. The control group consisted of children with acute otitis media who were not given antibiotics (n = 15). One species-level phylotype assigned to the genus Streptococcus was identified across all (n = 99) saliva samples. Two additional species-level phylotypes from the genera Gemella and Granulicatella were shared by all (n = 45) samples of control subjects. Amoxicillin treatment resulted in reduced species richness and diversity, and a significant shift in the relative abundance of 35 taxa at different ranks from phylum to species-level phylotype. At the phylum level, prevalence of TM7 and Actinobacteria decreased at the end of treatment, whereas Proteobacteria had a higher relative abundance post-treatment. Multivariate analysis showed that samples from the same control subject taken over time intervals tended to cluster together. Among antibiotic-treated subjects, samples taken before and at the end of amoxicillin treatment formed two relatively well-separated clusters both of which greatly overlapped with samples taken about 3 weeks post-treatment. Our results point to a substantial but incomplete recovery of the salivary bacterial community from the antibiotic about 3 weeks after the end of treatment., (© 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.)

Objective: We sought to determine if use of more stringent diagnostic criteria for acute otitis media (AOM) than currently advocated by the American Academy of Pediatrics, tympanocentesis and pathogen-specific antibiotic treatment (individualized care) would result in reducing the incidence of recurrent AOM and consequent tympanostomy tube surgery., Methods: A 5-year longitudinal, prospective study in Rochester, NY, was conducted from July 2006 to July 2011 involving 254 individualized care children. When this individualized care group developed symptoms of AOM, strict diagnostic criteria were applied and a tympanocentesis was performed. Pathogen resistance to empiric high-dose amoxicillin/clavulanate (80 mg/kg of amoxicillin component) caused a change in antibiotic to an optimized choice. Legacy controls (n = 208) were diagnosed with the same diagnostic criteria by the same physicians as the individualized care group and received the same empiric amoxicillin/clavulanate (80 mg/kg of amoxicillin component) but no tympanocentesis or change in antibiotic. Community control children (n = 1020) were diagnosed according to current American Academy of Pediatrics guidelines and treated with high-dose amoxicillin (80 mg/kg) without tympanocentesis as guideline recommended., Results: 5.9% of children of the individualized care group compared with 14.4% of Legacy controls and 27.3% of community controls became otitis prone, defined as 3 episodes of AOM within a 6-month time span or 4 AOM episodes within a 12-month time span (P < 0.0001). 2.4% of the individualized care group compared with 6.3% of Legacy controls, and 14.8% of community controls received tympanostomy tubes (P < 0.0001)., Conclusions: Individualized care of AOM significantly reduces the frequency of AOM and tympanostomy tube surgery. Use of strict diagnostic criteria for AOM and empiric antibiotic treatment using evidence-based knowledge of circulating otopathogens and their antimicrobial susceptibility profile also produces improved outcomes.

Acute otitis media (AOM) is diagnosed based on visualization of a full or bulging tympanic membrane with middle ear effusion. The distribution of bacteria causing AOM in North America under the influence of pneumococcal conjugate vaccination and antibiotic selection pressure has resulted in a predominance of β-lactamase-producing Haemophilus influenzae followed by penicillin-resistant Streptococcus pneumoniae. Although guidelines continue to endorse amoxicillin as the preferred treatment, amoxicillin/clavulanate in high dosage would be the preferred treatment based on the otopathogen mix currently. Antibiotic prophylaxis has fallen into disfavor as a preventative strategy for AOM recurrences., (Copyright © 2013 Elsevier Inc. All rights reserved.)

This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians. It provides recommendations to primary care clinicians for the management of children from 6 months through 12 years of age with uncomplicated AOM. In 2009, the AAP convened a committee composed of primary care physicians and experts in the fields of pediatrics, family practice, otolaryngology, epidemiology, infectious disease, emergency medicine, and guideline methodology. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the new literature related to AOM since the initial evidence report of 2000. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific, stringent definition of AOM. It addresses pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotic agents, and preventive measures. It also addresses recurrent AOM, which was not included in the 2004 guideline. Decisions were made on the basis of a systematic grading of the quality of evidence and benefit-harm relationships. The practice guideline underwent comprehensive peer review before formal approval by the AAP. This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.

Objective: To conduct a systematic review comparing the effect of three interventions (prophylactic antibiotics, tympanostomy tube insertion and adenoidectomy) on otitis media recurrence, recurrence frequency and total recurrence time., Methods: Literature on recurrent otitis media was identified using the PubMed and Scopus search engines for the period January 1990 to March 2011. A hand search of the reference lists of relevant articles and textbooks was conducted to identify additional studies. Randomised, controlled trials with a minimum of 40 children and follow up of at least 12 months were included., Results: Eighteen publications were identified. Each was assessed using preset inclusion criteria; seven publications met these criteria., Conclusion: Prophylactic antibiotics are effective in reducing otitis media recurrence, recurrence frequency and total recurrence time. Tympanostomy tube insertion failed to reduce the prevalence of otitis media recurrence, but reduced the recurrence frequency and total recurrence time. Adenoidectomy reduced otitis media recurrence; results on otitis media recurrence frequency differed but on average there was a reduction; however, the two studies with relevant data on total recurrence time had contradictory results.

Question: As concern about antimicrobial resistance grows, I am aware of the need to reduce unnecessary antibiotic treatment; however, in my practice I see many children with acute otitis media (AOM) and this is the most common reason I prescribe antibiotics. Most of these children are young and otherwise healthy, and I am uncertain about when to prescribe antibiotics and when to endorse "watchful waiting." Which children will benefit from antibiotic treatment?, Answer: Current Canadian guidelines recommend all children younger than 2 years of age with otalgia due to AOM and fever greater than 39°C be considered for treatment with amoxicillin. Watchful waiting is indicated only for children older than 6 months with mild-to-moderate AOM. Recent evidence suggests young children with a definitive diagnosis of AOM will benefit from antibiotics and experience fewer treatment failures compared with placebo, regardless of the severity of otitis. These studies do not challenge watchful waiting directly, and determining which children will improve spontaneously remains an enigma.

Introduction: Acute otitis media is the most common respiratory tract infection in infancy and early childhood that is managed with antimicrobial agents. Ninety-three per cent of the cases diagnosed in Spain are treated with antibiotics, and Streptococcus pneumoniae and untypeable Haemophilus influenzae are the most frequently isolated pathogens. The aim of this work was to evaluate the usefulness of amoxicillin, amoxicillin/clavulanate and ceftriaxone for the empirical treatment of acute otitis media, looking at the pharmacokinetic variability and the antimicrobial susceptibility of paediatric strains of the two main pathogens responsible for AOM in Spain, Streptococcus pneumoniae and Haemophilus influenzae., Methods: Free-drug plasma concentrations were simulated and the probability of target attainment at each minimum inhibitory concentration and the cumulative fraction of response (CFR) were determined. Microbiological susceptibility information was extracted from SAUCE 3 surveillance., Results: CFR with amoxicillin varied from 83% to 96% against S. pneumoniae and from 78% to 86% against H. influenzae. CFR was always >85% with amoxicillin/clavulanate. With the 3-day ceftriaxone regimen, the probability of achieving free concentrations above MIC at 72 hours significantly increased compared to the single dose, with which CFR ranged from 70% to 84%., Conclusions: High-dose amoxicillin (at least 80 mg/kg/day) should be the first-line therapy in uncomplicated infections, whereas amoxicillin/clavulanate (40 mg/kg/day) should be the choice when additional coverage for H. influenzae is desired. Administration of 3 daily doses of ceftriaxone increases bacteriological eradication probability when compared with one-day regimen, although additional clinical evaluations are necessary to establish the best target attainment with ceftriaxone., (Copyright © 2009 Elsevier España, S.L. All rights reserved.)

Objective: To provide recommendations for 1) prevention of acute otitis media and meningitis via immunization and 2) antimicrobial therapy of acute otitis media and meningitis in children with cochlear implants., Data Sources: Literature review and policy statement from the American Academy of Pediatrics., Conclusion: 1) Children who are candidates for cochlear implants or have received cochlear implants should receive all-age appropriate vaccinations, including indicated doses of 13-valent pneumococcal conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, and influenza vaccine. A supplemental dose of 13-valent pneumococcal conjugate vaccine is indicated for children who have received indicated doses of 7-valent pneumococcal vaccine, but have not received 13-valent pneumococcal conjugate vaccine. In addition, children 24 months and older should receive a single dose of 23-valent pneumococcal polysaccharide vaccine. 2) Acute otitis media in children with cochlear implants should be treated with an antimicrobial. During the first 2 months after implant, initial treatment of acute otitis media with a parenteral antimicrobial, e.g., cetriaxone, is indicated. High-dose amoxicillin or amoxicillin-clavulanate is an appropriate antimicrobial choice for empiric treatment of acute otitis media occurring 2 or more months after implant. In cases of meningitis occurring during the first 2 months after implantation, broad spectrum empiric antimicrobial therapy, e.g., meropenem and vancomycin, should be initiated pending the results of CSF culture. Empiric antimicrobial therapy with ceftriaxone and vancomycin is appropriate for cases of meningitis occurring 2 or more months after implant.

Objective: Mastoiditis, subperiosteal abscess and sigmoid vein thrombosis are the most common suppurative complications of acute otitis media (AOM). Luc's abscess, a subperiosteal temporal collection, is an infrequent complication with a particularly benign course., Patients: Two children, aged 5 years, presented with AOM complicated by an atypical abscess deep to the temporalis muscle, with no evidence for mastoid or zygomatic arch involvement., Intervention(s): Computed tomographic scan was performed in only 1 child. In both children, treatment included antibiotic therapy, grommet insertion, and local surgical drainage of the temporalis abscess. In addition, a cortical mastoidectomy was performed in the patient who did not undergo computed tomography, based on clinical assessment., Main Outcome Measure(s): Clinical improvement, resolution of symptoms., Results: Both patients recovered shortly following the surgical drainage. Mastoidectomy was poor in findings and was concluded as redundant., Conclusion: Luc's abscess is associated with relatively little morbidity and requires a more limited surgical intervention. Computed tomographic scan is of great value to evaluate the extent of the disease and prevent needless mastoidectomy.

Background: Macrolide antibiotics are often used to treat children with acute otitis media (AOM); however, the 2004 American Academy of Pediatrics (AAP) and American Academy of Family Physicians guidelines recommend against their use in patients without history of a type I allergic reaction to penicillins., Objective: To evaluate via meta-analysis the comparative efficacy of amoxicillin or amoxicillin/clavulanate to that of macrolide antibiotics in the treatment of children with AOM., Methods: A systematic literature search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted from the earliest available date through September 2008. We used the following MeSH and key words: amoxicillin, amoxicillin/clavulanate, Augmentin, azithromycin, ceftriaxone, clarithromycin, macrolides, AND media, otitis media, and effusion. Included studies were randomized, blinded, and controlled trials evaluating guideline-recommended antibiotics (amoxicillin or amoxicillin/clavulanate) compared to macrolide antibiotics (azithromycin or clarithromycin) in AOM in children. The primary outcome assessed was clinical failure measured between days 10 and 16 after starting antibiotic therapy. Results are reported as relative risks (RRs) with 95% confidence intervals and were calculated using a random-effects model., Results: A total of 10 trials (N = 2766) evaluating children 6 months-15 years old were included in the meta-analysis. Upon meta-analysis, the use of macrolide antibiotics was associated with an increased risk of clinical failure (RR 1.31 [95% CI 1.07 to 1.60]; p = 0.008) corresponding to a number needed to harm of 32. Upon safety analysis, rates of any adverse reaction (RR 0.74 [95% CI 0.60 to 0.90]; p = 0.003) and diarrhea (RR 0.41 [95% CI 0.32 to 0.52]; p < 0.0001) were significantly lower in the macrolide group., Conclusions: The meta-analysis suggests that patients treated with macrolides for AOM may be more likely to have clinical failures. As such, it supports the current AAP AOM recommendation that macrolides be reserved for patients who can not receive amoxicillin or amoxicillin/clavulanate.

Objective: To compare the clinical effectiveness of single-dose azithromycin treatment with 7 days of amoxycillin treatment among Aboriginal children with acute otitis media (AOM) in rural and remote communities in the Northern Territory., Design, Setting and Participants: Aboriginal children aged 6 months to 6 years living in 16 rural and remote communities were screened for AOM. Those diagnosed with AOM were randomly allocated to receive either azithromycin (30 mg/kg as a single dose) or amoxycillin (50mg/kg/day in two divided doses for a minimum of 7 days). We used a double-dummy method to ensure blinding. Our study was conducted from 24 March 2003 to 20 July 2005., Main Outcome Measures: Failure to cure AOM by the end of therapy; nasal carriage of Streptococcus pneumoniae and non-capsular Haemophilus influenzae (NCHi)., Results: We followed 306 of 320 children (96%) allocated to the treatment groups. Single-dose azithromycin did not reduce (or increase) the risk of clinical failure (50% failure rate [82/165]) compared with amoxycillin (54% failure rate [83/155]) (risk difference [RD], - 4% [95% CI, - 15% to 7%]; P = 0.504). Compared with amoxycillin, azithromycin significantly reduced the proportion of children with nasal carriage of S. pneumoniae (27% v 63%; RD, - 36% [95% CI, - 47% to - 26%]; P < 0.001) and NCHi (55% v 85%; RD, - 30% [95% CI, - 40% to - 21%]; P < 0.001). Nasal carriage of S. pneumoniae with intermediate or full resistance to penicillin was lower (but not significantly so) in the azithromycin group (10% v 16%), but this group had significantly increased carriage of azithromycin-resistant S. pneumoniae (10% v 3%; RD, 7% [95% CI, 0.1% to 12%]; P = 0.001). Carriage of beta-lactamase-producing NCHi was about 5% in both groups., Conclusion: Although azithromycin reduced nasal carriage of S. pneumoniae and NCHi, clinical failure was high in both treatment groups. The possibility of weekly azithromycin treatment in children with persistent AOM should be evaluated., Trial Registration: Australian Clinical Trials Registry ACTRN 12609000691246.

Health-care professionals who manage children are regularly confronted with clinical questions regarding the management of the full spectrum of otitis media: acute otitis media; otitis media with effusion; and chronic suppurative otitis media. Given the variety of potential therapies available, the wide spectrum of middle ear disorders, and the lack of consensus about management strategies, clinicians are in a difficult position when managing these children. In this review, we seek to summarise the current best evidence for answering otitis media management questions by collating existing systematic reviews.

Objectives: The aims of this study are to evaluate biofilm formation by nontypeable Haemophilus influenzae (NTHi) isolated from children with acute otitis media (AOM) and its relation with clinical outcome of the disease., Methods: Biofilm formations by NTHi clinical isolates from pediatric AOM patients were evaluated by a crystal violet microtiter plate and a 98 well pin-replicator assay with a confocal laser scanning microscopy (CLSM). Optical density values of clinical isolates were compared with a positive control and the ratio of clinical isolates to a positive control was defined as biofilm formation index (BFI)., Results: 84.3% clinical isolates of NTHi were biofilm forming strains (BFI> or =0.4). The BFI represented the levels of biofilm formation and adherence on the surface. The identical strains isolated from both middle ear fluids (MEFs) and nasopharynx showed biofilm formation at the same level. The prevalence of biofilm forming isolates was significantly higher among the susceptible strains than resistant strains. The level of biofilm formation of NTHi isolated from AOM cases who was not improved by amoxicillin (AMPC) was significantly higher than that of NTHi isolated from AOM cases who was improved by AMPC., Conclusion: We clearly showed the biofilm formation of clinical NTHi isolates from AOM children. In addition, the biofilm formed by NTHi would play an important role in persistent or intractable clinical course of AOM as a result of lowered treatment efficacy of antibiotics.

Objective: To determine the long term effects of antibiotic treatment for acute otitis media in young children., Design: Prospective three year follow-up study within the framework of a primary care based, double blind, randomised, placebo controlled trial., Setting: 53 general practices in the Netherlands., Participants: 168 children aged 6 months to 2 years with acute otitis media., Interventions: Amoxicillin 40 mg/kg/day in three doses compared with placebo., Main Outcome Measures: Recurrence of acute otitis media; referral to secondary care; ear, nose, and throat surgery., Results: Acute otitis media recurred in 63% (47/75) of children in the amoxicillin group and in 43% (37/86) of the placebo group (risk difference 20%, 95% confidence interval 5% to 35%); 30% (24/78 amoxicillin; 27/89 placebo) of children in both groups were referred to secondary care, and 21% (16/78) of the amoxicillin group compared with 30% (27/90) of the placebo group had ear, nose, and throat surgery (risk difference -9%, -23% to 4%)., Conclusion: Recurrent acute otitis media occurred more often in the children originally treated with amoxicillin. This is another argument for judicious use of antibiotics in children with acute otitis media. Trial registration Netherlands Trial Register NTR1426.

Background: Overuse of broad-spectrum antibiotics is associated with antibiotic resistance. Acute otitis media (AOM) is responsible for a large proportion of antibiotics prescribed for US children. Rates of broad-spectrum antibiotic prescribing for AOM are unknown., Methods: Analysis of the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey, 1998 to 2004 (N = 6,878). Setting is office-based physicians, hospital outpatient departments, and emergency departments. Patients are children aged 12 years and younger prescribed antibiotics for acute otitis media. Main outcome measure is percentage of broad-spectrum antibiotics, defined as amoxicillin/clavulanate, macrolides, cephalosporins and quinolones., Results: Broad-spectrum prescribing for acute otitis media increased from 34% of visits in 1998 to 45% of visits in 2004 (P < .001 for trend). The trend was primarily attributable to an increase in prescribing of amoxicillin/clavulanate (8% to 15%; P < .001 for trend) and macrolides (9% to 15%; P < .001 for trend). Prescribing remained stable for amoxicillin and cephalosporins while decreasing for narrow-spectrum agents (12% to 3%; P < .001 for trend) over the study period. Independent predictors of broad-spectrum antibiotic prescribing were ear pain, non-white race, public and other insurance (compared to private), hospital outpatient department setting, emergency department setting, and West region (compared to South and Midwest regions), each of which was associated with lower rates of broad-spectrum prescribing. Age and fever were not associated with prescribing choice., Conclusion: Prescribing of broad-spectrum antibiotics for acute otitis media has steadily increased from 1998 to 2004. Associations with non-clinical factors suggest potential for improvement in prescribing practice.

Background: Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment., Results: The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991) is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations., Conclusion: A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.