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OBJECTIVE. The goal was to determine the clinical effectiveness of prolonged outpatient treatment with trimethoprim/sulfamethoxazole for children with chronic active otitis media. METHODS. We performed a randomized, placebo-controlled trial with 101 children (1-12 years of age) with chronic active otitis media (defined as otorrhea for [greater than or equal to] 12 weeks). In addition to a short course of steroid and antibiotic eardrops, children were assigned randomly to receive 6 to 12 weeks of orally administered trimethoprim/sulfamethoxazole (18 mg/kg, 2 times per day) or placebo and were monitored for 1 year. RESULTS. At 6 weeks, 28% of children in the trimethoprim/sulfamethoxazole group and 53% of children in the placebo group had otomicroscopic signs of otorrhea. At 12 weeks, these values were 32% and 47%, respectively. At 1 year, the numbers of children with otorrhea were similar in the 2 groups (25% and 20%, respectively). One child in the trimethoprim/sulfamethoxazole group developed a skin rash. Vomiting or diarrhea was reported for 9% of the trimethoprim/sulfamethoxazole group and 2% of the placebo group. Pure-tone hearing levels and health-related quality of life improved during the study but did not differ between the trimethoprim/sulfamethoxazole group and the placebo group. Pseudomonas aeruginosa was the most frequently isolated bacteria in the otorrhea samples from both groups. CONCLUSIONS. A 6- to 12-week course of high-dose, orally administered trimethoprim/ sulfamethoxazole therapy is beneficial for children with chronic active otitis media. The treatment effect is most pronounced with the shorter course and disappears if administration of the medication is discontinued. www.pediatrics.org/cgi/doi/10.1542/peds.2006-2787 doi:10.1542/peds.2006-2787 Key Words chronic suppurative otitis media, children, drug therapy, trimethoprim/sulfamethoxazole combination Abbreviations COM--chronic active otitis media NNT--number needed to treat RD--rate difference CI--confidence interval, CHRONIC ACTIVE (MUCOSAL) otitis media (COM) is a common infectious disease, affecting children in both developing and industrialized countries. (1-3) It causes considerable morbidity and is a major global cause [...]

BACKGROUND. Reported trends regarding the incidence of otitis media and antibiotic prescription rates are inconsistent. OBJECTIVE. Our goal was to assess changes in incidence of consultation rates, antibiotic prescription, and referral rates for otitis media in children over the years 1995-2003. METHODS. A cohort study including all children aged 0 to 13 years within the research database of the Netherlands University Medical Center Utrecht Primary Care Network covering the period 1995-2003. Otitis media diagnoses were recorded according to the International Classification of Primary Care codes and antibiotic prescription according to the Anatomic Therapeutic Chemical Classification System codes. Otitis media incidence rates were calculated as episodes per 1000 person-years. Antibiotic prescription and referral rates were calculated per 100 otitis media episodes. RESULTS. From 1995 to 2003, the overall general practitioner consultation rates for acute otitis media and otitis media with effusion declined by 9% and 34%, respectively. In children aged 2 to 6 years and those aged 6 to 13 years, the incidence rates of acute otitis media and otitis media with effusion declined by 15% and 41% and 40% and 48%, respectively. In children CONCLUSIONS. Consultation rates for otitis media have changed considerably over the last decade, and so have antibiotic prescriptions and specialist referrals. The rising antibiotic prescription rate for otitis media causes concern, because this may induce increasing medical costs and antibiotic resistance. Key Words otitis media, children, diagnostic rates, antibiotics, referrals Abbreviations OM--otitis media AOM--acute otitis media GP--general practitioner ICPC--International Classification of Primary Care OME--otitis media with effusion CI--confidence interval, OTITIS MEDIA (OM) is one of the most common infectious diseases in children and a major cause of doctor consultations and antibiotic prescriptions. (1,2) Direct and indirect costs are high: [...]

BACKGROUND. Otitis media with effusion (OME) is very common during childhood. Because Streptococcus pneumoniae is one of the most common bacterial pathogens involved in OME, pneumococcal vaccines may have a role in the prevention of recurrent OME. OBJECTIVE. We sought to assess the effect of combined pneumococcal conjugate and polysaccharide vaccinations on the recurrence of OME. METHODS. A randomized, controlled trial was performed with 161 children, 2 to 8 years of age, with documented persistent bilateral OME. All subjects were treated with tympanostomy tubes (TTs). One half of the subjects were assigned randomly to additional vaccination with a 7-valent pneumococcal conjugate vaccine 3 to 4 weeks before and a 23-valent pneumococcal polysaccharide vaccine 3 months after tube insertion. Blood samples were drawn at the first vaccination, at the time of TT placement, and 1 and 3 months after the second vaccination. Levels of IgA and IgG serum antibody against the 7-valent pneumococcal conjugate vaccine serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F were measured with enzyme-linked immunosorbent assays. All children were monitored for recurrence of OME for 6 months after spontaneous extrusion of the TTs. RESULTS. The overall recurrence rate of bilateral OME was 50%. Pneumococcal vaccinations induced significant 4.6- to 24.4-fold increases in the geometric means of all conjugate vaccine serotype antibody titers but did not affect recurrence of OME. CONCLUSIONS. Combined pneumococcal conjugate and polysaccharide vaccination does not prevent recurrence of OME among children 2 to 8 years of age previously known to have persistent OME. Therefore, pneumococcal vaccines are not indicated for the treatment of children suffering from recurrent OME. Key Words otitis media, effusion, pneumococcal, conjugate vaccine Abbreviations OME--otitis media with effusion TT--tympanostomy tube PCV7--7-valent pneumococcal conjugate vaccine PPV23--23-valent pneumococcal polysaccharide vaccine CI--confidence interval, OTITIS MEDIA WITH effusion (OME) is highly prevalent during childhood. (1) It is a self-limiting condition in most cases, but recurrences are frequent, with a cumulative recurrence rate of 50% [...]

Background. Limited effectiveness of current treatment strategies for recurrent acute otitis media (RAOM) and increasing antibiotic resistance have diverted attention to prevention of AOM by vaccination. Pneumococcal vaccination for AOM seems to have only modest clinical efficacy. Thus far, the effects on health-related quality of life (HRQoL) or functional health status (FHS) have not been studied. Objective. To assess the effect of vaccination on HRQoL or FHS. Methods. In a double-blind, randomized, controlled trial, 383 children 1 to 7 years old with RAOM were vaccinated with either heptavalent pneumococcal conjugate vaccine followed by pneumococcal polysaccharide vaccine (pneumococcal group: n = 190) or with hepatitis A or B vaccines (control group: n = 193). Parents completed validated Dutch versions of 8 HRQoL and FHS instruments assessing generic FHS (Rand, Functional Status Questionnaire specific, and Functional Status Questionnaire generic), otitis media-specific FHS (OM-6), otitis media-specific child HRQoL (Numerical Rating Scale for Child), family functioning (Family Functioning Questionnaire), and otitis media-specific caregiver HRQoL (Numerical Rating Scale for Caregiver). Scores were compared at baseline and at 14 and 26 months' follow-up. Results. At baseline, the average AOM incidence in the pneumococcal and control group was 5.0 (SD: 2.8) and 4.9 (SD: 2.6) episodes per year, respectively, with 38.4% and 36.8% having suffered from [greater than or equal to] 6 episodes per year. AOM frequency decreased 4.4 episodes per year in both groups, with a considerable and comparable improvement in HRQoL and FHS. No substantial differences in HRQoL or FHS were found between the pneumococcal and the control group at baseline or at 14 or 26 months' follow-up. Conclusion. Pneumococcal vaccination has no beneficial effect compared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM. health-related quality of life, acute otitis media, recurrent acute otitis media, functional health status, pneumococcal vaccination., ABBREVIATIONS. OM, otitis media; AOM, acute otitis media; RAOM, recurrent acute otitis media; HRQoL, health-related quality of life; FHS, functional health status; Rand, Rand general health rating index for children; [...]

Background: Acute otorrhea is a common problem in children with tympanostomy tubes. We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation. The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition., Methods: We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive 1 of 3 treatments: hydrocortisone-bacitracin-colistin eardrops, oral amoxicillin-clavulanate suspension, and initial observation (no assigned medication prescription to fill). Parents kept a daily diary capturing ear-related symptoms, health care resource use, and non-health care costs for 6 months. At 2 weeks and 6 months, the study doctor visited the children at home performing otoscopy. Using a societal perspective, treatment failure (otoscopic presence of otorrhea at 2 weeks) and number of days with otorrhea as reported in the daily diary were balanced against the costs., Results: Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months. At 2 weeks, mean total cost per patient was US$42.43 for antibiotic-glucocorticoid eardrops, US$70.60 for oral antibiotics, and US$82.03 for initial observation. At 6 months, mean total cost per patient was US$368.20, US$420.73, and US$640.44, respectively. Because of the dominance of eardrops, calculating incremental cost-effectiveness ratios was redundant., Conclusions: Antibiotic-glucocorticoid eardrops are clinically superior and cost less than oral antibiotics and initial observation in children with tympanostomy tubes who develop otorrhea., (Copyright © 2015 by the American Academy of Pediatrics.)