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Background: Most antibiotic use occurs in ambulatory settings. No benchmarks exist for pediatric institutions to assess their outpatient antibiotic use and compare prescribing rates to peers. We aimed to share pediatric outpatient antibiotic use reports and benchmarking metrics nationally., Methods: We invited institutions from the Sharing Antimicrobial Reports for Pediatric Stewardship OutPatient (SHARPS-OP) Collaborative to contribute quarterly aggregate reports on antibiotic use from January 2019 to June 2022. Outpatient settings included emergency departments (ED), urgent care centers (UCC), primary care clinics (PCC) and telehealth encounters. Benchmarking metrics included the percentage of: (1) all acute encounters resulting in antibiotic prescriptions; (2) acute respiratory infection (ARI) encounters resulting in antibiotic prescriptions; and among ARI encounters receiving antibiotics, (3) the percentage receiving amoxicillin ("Amoxicillin index"); and (4) the percentage receiving azithromycin ("Azithromycin index"). We collected rates of antibiotic prescriptions with durations ≤7 days and >10 days from institutions able to provide validated duration data., Results: Twenty-one institutions submitted aggregate reports. Percent ARI encounters receiving antibiotics were highest in the UCC (40.2%), and lowest in telehealth (19.1%). Amoxicillin index was highest for the ED (76.2%), and lowest for telehealth (55.8%), while the azithromycin index was similar for ED, UCC, and PCC (3.8%, 3.7%, and 5.0% respectively). Antibiotic duration of ≤7 days varied substantially (46.4% for ED, 27.8% UCC, 23.7% telehealth, and 16.4% PCC)., Conclusions: We developed a benchmarking platform for key pediatric outpatient antibiotic use metrics drawing data from multiple pediatric institutions nationally. These data may serve as a baseline measurement for future improvement work., (© The Author(s) 2023. 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.)

Background/objectives: Antibiotic indication documentation at the time of order entry is mandated by the Joint Commission. Inclusion of indication at order entry may have an impact on the time to administration. Our primary objective was to evaluate agreement between indication selected during order entry and clinical notes. Our secondary objective was to observe if there was a change in time to administration after indications were required during order entry., Methods: Patients ≤18 years old who received ≥1 dose of vancomycin or ceftriaxone during a preintervention period and 3 postintervention periods were included. Indication for use, agreement between order and clinical note, and timing of antibiotic administration were collected., Results: Most common indication for vancomycin (total: 789) was sepsis (26%, n = 204). Common indications for ceftriaxone (total: 1071) were sepsis (12%, n = 127), perforated appendicitis (12%, n = 125), and urinary tract infection (10%, n = 107). Postintervention, agreement between the indication selected during order entry and indication documented in clinical note for ceftriaxone and vancomycin orders were 41% and 46%, respectively. Median time to administration decreased among patients who received ceftriaxone ( P < .01) but had no significant impact on time to administration of vancomycin ( P = .49)., Conclusions: Indication for ceftriaxone and vancomycin selected during order entry and reported in clinical notes inconsistently matched. Inclusion of antibiotic indication may impact time to administration.

Background: Prolonged antibiotic therapy may be associated with increased adverse events and antibiotic resistance. We deployed an intervention in the electronic health record (EHR) to reduce antibiotic duration for pediatric outpatients., Methods: A preintervention and postintervention interrupted time series analysis of antibiotic duration for 7 antibiotics was performed for patients discharged from the ED and clinics of a children's hospital network from 2012 to 2018. In February 2015, clickable 5- and 7-day duration option buttons were deployed in the EHR for clindamycin, cephalexin, ciprofloxacin and levofloxacin, trimethoprim-sulfamethoxazole, amoxicillin, and cefdinir, with an additional 10-day option for the latter 2. Prescribers were able to enter a free-text duration. The option buttons were not announced, and were not linked to a specific diagnosis or quality improvement initiative. The primary outcome was proportion of prescriptions per month with duration of 10 days. Balancing secondary outcomes were reorders of the same agent, return to clinic, and inpatient admissions within 30 days., Results: There were 54 315 prescriptions for the 7 antibiotics associated with 39 894 patients, 18 683 clinic visits, and 35 632 ED visits. Overall, a -5.1% (95% confidence interval [CI], -8.3% to -2.0%) change in the proportion of prescriptions with a 10-day duration was attributable to the intervention, with larger effects noted for clindamycin (-20.8% [95% CI, -26.9% to -14.7%]) and cephalexin (-9.9% [95% CI, -14.3% to -5.4%]). There was no increase in the reorders of the same agent, return clinical encounters, or inpatient admissions within 30 days., Conclusions: A simple intervention in the EHR can safely reduce duration of antibiotic therapy., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 by the American Academy of Pediatrics.)

Purpose: Accelerate Pheno provides rapid identification and antimicrobial susceptibility tests (ASTs) of pathogens that cause blood stream infections (BSIs). The study objective was to assess the accuracy of the Accelerate Pheno platform and its impact on antimicrobial modification in children with gram-negative BSIs., Methods: A retrospective review was conducted of patients at a children's hospital with gram-negative BSIs from November 2018 to November 2019. Proportion of agreement between Accelerate Pheno and standard of care (SOC) was determined for organism identification (matrix-assisted laser desorption ionization time-of-flight mass spectrometry) and susceptibilities (MicroScan). Time from culture collection to Gram stain, identification and AST by the Accelerate Pheno method, and AST results by MicroScan were calculated. Antibiotic modifications and opportunities to optimize antimicrobial stewardship were recorded., Findings: Of 115 BSIs from 90 patients, 90 monomicrobial gram-negative BSIs with an organism included on the Accelerate Pheno panel were found. Compared with SOC, the organism was correctly identified in 90 patients (100%). Overall, 5 of 732 ASTs (0.7%) reported susceptible by Accelerate Pheno were resistant by SOC, and 8 of 109 (7.3%) reported resistant by Accelerate Pheno were susceptible by SOC. On the basis of the Accelerate Pheno AST results, antibiotic spectrum was increased in 10 of 11 instances to correct organism-drug mismatch and narrowed in 16 of 33 instances. Median times from culture collection to reporting of Gram stain, Accelerate Pheno identification, Accelerate Pheno AST, and SOC AST were 12.6, 14.6, 19.9, and 60.6 h, respectively. Median time to optimal therapy was 21.8 h for infections with actionable AST data., Implications: Accelerate Pheno was accurate and decreased time to optimal therapy by almost 40 h for children with gram-negative BSIs. Antibiotic spectrum was increased in multiple instances, but opportunities to decrease spectrum were underused., Competing Interests: Disclosures Sameer Patel has received consulting fees from Nexogen Inc. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: Approximately two thirds of the tonnage of antibiotics sold in the United States are intended for use in food production, and global use is projected to increase. This review summarizes the rationale for antibiotic use in animal agriculture, therapeutic classes used, risks from antibiotic-resistant organisms, and limits of existing regulation. In addition, opportunities for improved surveillance, stewardship, and advocacy will be highlighted., Methods: A transdisciplinary narrative review of drivers of antibiotics in food production was conducted, including concepts from population health, infectious diseases, veterinary medicine, and consumer advocacy., Findings: Globally, antibiotics of many important classes in human medicine are given to animals for the treatment of a diagnosed illness, disease control and prevention, and growth promotion. Extensive antibiotic use on farms drives the emergence of antibiotic-resistant organisms in food-producing animals, which can be transmitted to people and the environment. Antibiotic stewardship in food production has been associated with decreased rates of resistance in both animals and humans, without reducing farm productivity. Multiple European nations have successfully implemented stewardship strategies, including banning uses for disease prevention, benchmarking antibiotic utilization, and setting national reduction targets. In the United States, medically important antibiotics are no longer permitted for growth promotion; however, antibiotics may be prescribed for other indications with limited veterinary oversight and requirements for reporting. Marked reductions in use have been achieved in the poultry industry, although use in the pork and beef industries remain high., Implications: Despite some progress, significant challenges in surveillance and regulatory oversight remain to prevent the overuse of antibiotics in food production. Consumers remain a potent force via market pressure on grocery stores, restaurants, suppliers, and farmers. Improved, verified labelling is important for informing consumer choices. Numerous public health agencies, consumer groups, and professional societies have called for judicious antibiotic use, but increased direct advocacy from health care professionals is needed., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: Peritonsillar (PT), parapharyngeal (PP), and retropharyngeal (RP) abscesses are common pediatric deep neck space infections (DNSI). Despite established literature on DNSI microbiology, obtaining intraoperative cultures remains commonplace. The objective was to evaluate the resource utilization of intraoperative cultures when draining PT, PP, and RP abscesses., Methods: Pediatric patients (age <18.0 years) who underwent surgical drainage of a PT, PP, or RP abscess between January 2013 and June 2018 were retrospectively reviewed. Changes in antimicrobials based on intraoperative culture results were assessed by use of Fisher's exact tests or Wilcoxon rank-sum tests, as appropriate. Multivariable linear regression was used to model the association between factors of interest and number of cultures obtained., Results: Eighty-eight patients underwent surgical drainage, of which 80 patients (median age 6.96 years) had intraoperative bacterial cultures (32 PT, 21 PP, and 27 RP). There were no positive fungal or acid-fast bacilli cultures. Seven patients had culture-directed changes in treatment; none of these patients had a PT abscess. Age was inversely associated with culture-directed changes (p = 0.006) while the use of blood cultures (p = 0.012) was positively associated with culture-directed treatment changes. Hospital length of stay (p < 0.001) and history of prior DNSI (p = 0.001) were associated with number of cultures obtained., Conclusions: Younger children with PP and RP abscesses are most likely to benefit from intraoperative bacterial cultures. Cultures of PT abscesses are unlikely to change clinical management. Fungal and acid-fast bacilli cultures are unlikely to yield clinically useful information. Prudent use of intraoperative cultures may decrease the use of hospital resources and admission-related costs., Competing Interests: Declaration of competing interest The authors have no funding, financial relationships, or conflicts of interest to disclose., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Implementing matrix-assisted laser desorption ionization-time of flight and multiplex polymerase chain reaction has been associated with decreased mortality and hospital length of stay in adults, but the impact in pediatrics is less understood., Methods: This pre-post quasi-experimental study compared antibiotic prescribing for positive blood cultures in patients ≤21 years of age collected in 2012 (preintervention) and in 2015 (after matrix-assisted laser desorption ionization-time of flight/multiplex polymerase chain reaction). Time to effective and optimal antimicrobial therapy was evaluated using Cox proportional hazards regression. Time to ideal optimal therapy was estimated as the earliest potential initiation of optimal therapy. Antibiotic use and clinical outcomes were measured., Results: There were 242 and 192 positive monomicrobial blood cultures in 2012 and 2015, respectively. Postintervention, time to optimal therapy (73.8 vs. 48.8 hours; P < 0.001) and organism identification (55.6 vs. 29.5 hours; P < 0.001) were reduced, and patients were more likely to receive optimal therapy by 7 days (hazard ratio, 1.85; P < 0.001). In the ideal scenario in 2015, there was an 8.8-hour delay in initiating optimal therapy based on the time that sufficient microbiologic data were available. Postintervention, time to effective therapy (2.8 vs. 2.7 hours; P = 0.782) and clinical outcomes did not differ. Unnecessary antibiotic duration for probable contaminants (skin flora) (43.1 vs. 29.7 hours; P = 0.027), vancomycin for methicillin-sensitive Staphylococcus aureus (54.0 vs. 41.3 hours; P = 0.008) and nonpenicillin/ampicillin antibiotics for group A Streptococcus, group B Streptococcus and Enterococcus faecalis (87.2 vs. 33.4 hours; P < 0.001) were reduced postintervention., Conclusions: Rapid diagnostics reduced time to optimal antimicrobial therapy and unnecessary antibiotic use without worse clinical outcomes.

Traditional antibiograms can guide empiric antibiotic therapy, but they may miss differences in resistance across patient subpopulations. In this retrospective descriptive study, we constructed and validated antibiograms using International Classification of Disease, Tenth Revision (ICD-10) codes and other discrete data elements to define a cohort of previously healthy children with urinary tract infections. Our results demonstrate increased antibiotic susceptibility. This methodology may be modified to create other syndrome-specific antibiograms.

The prevalence of pediatric antimicrobial stewardship programs (ASPs) is increasing in acute care facilities across the United States. Over the past several years, the evidence base used to inform effective stewardship practices has expanded, and regulatory interest in stewardship programs has increased. Here, we review approaches for established, hospital-based pediatric ASPs to adapt and report standardized metrics, broaden their reach to specialized populations, expand to undertake novel stewardship initiatives, and implement rapid diagnostics to continue their evolution in improving antimicrobial use and patient outcomes.

Objectives: To characterize and compare antibiotic prescribing across PICUs to evaluate the degree of variability., Design: Retrospective analysis from 2010 through 2014 of the Pediatric Health Information System., Setting: Forty-one freestanding children's hospital., Subjects: Children aged 30 days to 18 years admitted to a PICU in children's hospitals contributing data to Pediatric Health Information System., Interventions: To normalize for potential differences in disease severity and case mix across centers, a subanalysis was performed of children admitted with one of the 20 All Patient Refined-Diagnosis Related Groups and the seven All Patient Refined-Diagnosis Related Groups shared by all PICUs with the highest antibiotic use., Results: The study included 3,101,201 hospital discharges from 41 institutions with 386,914 PICU patients. All antibiotic use declined during the study period. The median-adjusted antibiotic use among PICU patients was 1,043 days of therapy/1,000 patient-days (interquartile range, 977-1,147 days of therapy/1,000 patient-days) compared with 893 among non-ICU children (interquartile range, 805-968 days of therapy/1,000 patient-days). For PICU patients, the median adjusted use of broad-spectrum antibiotics was 176 days of therapy/1,000 patient-days (interquartile range, 152-217 days of therapy/1,000 patient-days) and was 302 days of therapy/1,000 patient-days (interquartile range, 220-351 days of therapy/1,000 patient-days) for antimethicillin-resistant Staphylococcus aureus agents, compared with 153 days of therapy/1,000 patient-days (interquartile range, 130-182 days of therapy/1,000 patient-days) and 244 days of therapy/1,000 patient-days (interquartile range, 203-270 days of therapy/1,000 patient-days) for non-ICU children. After adjusting for potential confounders, significant institutional variability existed in antibiotic use in PICU patients, in the 20 All Patient Refined-Diagnosis Related Groups with the highest antibiotic usage and in the seven All Patient Refined-Diagnosis Related Groups shared by all 41 PICUs., Conclusions: The wide variation in antibiotic use observed across children's hospital PICUs suggests inappropriate antibiotic use.

Objectives: To assess trends in the duration of intravenous (IV) antibiotics for urinary tract infections (UTIs) in infants ≤60 days old between 2005 and 2015 and determine if the duration of IV antibiotic treatment is associated with readmission., Methods: Retrospective analysis of infants ≤60 days old diagnosed with a UTI who were admitted to a children's hospital and received IV antibiotics. Infants were excluded if they had a previous surgery or comorbidities, bacteremia, or admission to the ICU. Data were analyzed from the Pediatric Health Information System database from 2005 through 2015. The primary outcome was readmission within 30 days for a UTI., Results: The proportion of infants ≤60 days old receiving 4 or more days of IV antibiotics (long IV treatment) decreased from 50% in 2005 to 19% in 2015. The proportion of infants ≤60 days old receiving long IV treatment at 46 children's hospitals varied between 3% and 59% and did not correlate with readmission (correlation coefficient 0.13; P = .37). In multivariable analysis, readmission for a UTI was associated with younger age and female sex but not duration of IV antibiotic therapy (adjusted odds ratio for long IV treatment: 0.93 [95% confidence interval 0.52-1.67])., Conclusions: The proportion of infants ≤60 days old receiving long IV treatment decreased substantially from 2005 to 2015 without an increase in hospital readmissions. These findings support the safety of short-course IV antibiotic therapy for appropriately selected neonates., Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Lee has received institutional grant funding from Merck that is unrelated to the current study; the other authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2017 by the American Academy of Pediatrics.)

The rising incidence of Clostridium difficile infections (CDIs) in adults is partly related to the global spread of fluoroquinolone-resistant strains, namely, BI/NAP1/027. Although CDIs are also increasingly diagnosed in children, BI/NAP1/027 is relatively uncommon in children. Little is known about the antibiotic susceptibility of pediatric CDI isolates. C. difficile was cultured from tcdB-positive stools collected from children diagnosed with CDI between December 2012 and December 2013 at an academic children's hospital. CDI isolates were grouped by restriction endonuclease analysis (REA). MICs were measured by agar dilution method for 7 antibiotics. Susceptibility breakpoints were based on guidelines from CLSI and/or the European Committee on Antimicrobial Susceptibility Testing (EUCAST). MICs and REA groupings of C. difficile isolates from 74 adult patients (29 isolates underwent REA) from a temporally and geographically similar adult cohort were compared to those of pediatric isolates. Among 122 pediatric and 74 adult isolates, respectively, the rates of resistance were as follows: metronidazole, 0% and 0%; vancomycin, 0% and 8% (P = 0.003); rifaximin, 1.6% and 6.7% (P = 0.11); clindamycin, 18.9% and 25.3% (P = 0.29); and moxifloxacin, 2.5% and 36% (P = <0.0001). Only 1 of 122 (0.8%) BI/NAP1/027 isolates was identified among the children, compared to 9 of 29 (31%) isolates identified among the adults (P = <0.0001). The 3 moxifloxacin-resistant pediatric isolates were of REA groups BI and CF and a nonspecific group. The 2 rifaximin-resistant pediatric isolates were of REA groups DH and Y. The 21 clindamycin-resistant pediatric isolates were distributed among 9 REA groups (groups A, CF, DH, G, L, M, and Y and 2 unique nonspecific REA groups). These data suggest that a diverse array of relatively antibiotic-susceptible C. difficile strains predominate in a cohort of children with CDI compared to adults., (Copyright © 2016, American Society for Microbiology. All Rights Reserved.)

There are unique challenges to antimicrobial stewardship in neonatal intensive care units (NICUs). Diagnosis of infection is difficult as neonates can have nonspecific signs and symptoms. Between and within NICUs, significant variation exists in the treatment duration of suspected sepsis and pneumonia. Development of multidisciplinary teams and meaningful metrics are essential for sustainable antibiotic stewardship. Potential stewardship interventions include optimizing culturing techniques, guiding empiric therapy by NICU-specific antibiograms, using ancillary laboratory tests, and promptly discontinuing therapy once infection is no longer suspected. Use of large neonatal databases can be used to benchmark antibiotic use and conduct comparative effectiveness research., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The judicious use of antibiotics is an important means to limit the emergence of antibiotic-resistant organisms. Although specific guidelines for neonates are often lacking, antibiotic stewardship principles can be applied to the neonatal intensive care unit. Principles include accurately identifying patients who need antibiotic therapy, using local epidemiology to guide the selection of empiric therapy, avoiding agents with overlapping activity, adjusting antibiotics when culture results become available, monitoring for toxicity, and optimizing the dose, route, and duration of therapy. Neonatal intensive care units should develop interdisciplinary antimicrobial stewardship teams with the support of their institutions. Prescriber audit and feedback, as well as preauthorization and formulary restriction of selected antibiotics, are recommended antimicrobial stewardship interventions. Ancillary strategies include education and computerized decision support. Metrics to evaluate antimicrobial stewardship programs should include measurements of patient safety and quality, such as rates of adverse drug events, and appropriate dosing and timing of perioperative prophylaxis., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to describe patterns of infection or colonization with antibiotic-resistant gram-negative bacilli (GNB) in hospitalized children utilizing an electronic health record., Setting: Tertiary care facility., Participants: Pediatric patients 18 years of age or younger hospitalized from January 1, 2006, to December 31, 2008., Methods: Children were identified who had (1) at least 1 positive culture for a multidrug-resistant (MDR) GNB, defined as a GNB with resistance to 3 or more antibiotic classes; or (2) additive drug resistance, defined as isolation of more than 1 GNB that collectively as a group demonstrated resistance to 3 or more antibiotic classes over the study period. Differences in clinical characteristics between the 2 groups were ascertained, including history of admissions and transfers, comorbid conditions, receipt of procedures, and antibiotic exposure., Results: Of 56,235 pediatric patients, 46 children were infected or colonized with an MDR GNB, of which 16 were resistant to 3 classes and 30 were resistant to 4 classes. Another 39 patients had positive cultures for GNB that exhibited additive drug resistance. Patients with additive drug resistance were more likely than patients with MDR GNB to have had previous admissions to a long-term facility (8 vs 2; P = .04) and had more mean admissions (7 vs 3; P < .01) and more mean antibiotic-days (P < .01 to P = .02). Six patients with additive drug resistance later had a positive culture with an MDR GNB., Conclusions: An electronic health record can be used to track antibiotic class resistance in GNB isolated from hospitalized children over multiple cultures and hospitalizations.

Objective: To use clinical vignettes to understand antimicrobial prescribing practices in neonatal intensive care units (NICUs)., Design: Vignette-based survey., Setting: Four tertiary care NICUs., Participants: Antibiotic prescribers in NICUs., Methods: Clinicians from 4 tertiary care NICUs completed an anonymous survey containing 12 vignettes that described empiric, targeted, or prophylactic antibiotic use. Responses were compared with Centers for Disease Control and Prevention guidelines for appropriate use., Results: Overall, 161 (59% of 271 eligible respondents) completed the survey, 37% of whom had worked in NICUs for 7 or more years. Respondents were more likely to appropriately identify use of targeted therapy for methicillin-susceptible Staphylococcus aureus, that is, use of oxacillin rather than vancomycin, than for Escherichia coli, that is, use of first-generation rather than third-generation cephalosporin, (P < .01). Increased experience significantly predicted appropriate prescribing (P = .02). The proportion of respondents choosing appropriate duration of postsurgical prophylaxis (P < .01) and treatment for necrotizing enterocolitis differed by study site (P = .03)., Conclusions: The survey provides insight into antibiotic prescribing practices and informs the development of future antibiotic stewardship interventions for NICUs.

Background: The Centers for Disease Control and Prevention (CDC) 12-Step Campaign to Prevent Antimicrobial Resistance was launched to educate clinicians about antimicrobial resistance and provide strategies to improve clinical practice, including antimicrobial utilization., Methods: A multicenter retrospective observational study of antibiotic use was performed in 4 tertiary care NICUs to assess adherence to the guidelines defined by the CDC 12-Step Campaign using predetermined criteria. Fifty infants per NICU were identified who received intravenous antibiotics at greater than 72 hours of age. Antibiotic regimens, clinical and microbiologic data, and indications for initiation and continuation of antibiotics (after 72 hours of use) were recorded. Inappropriate utilization was characterized at initiation, continuation, by agent, and by CDC 12-Step., Results: Two hundred neonates received 323 antibiotic courses totaling 3344 antibiotic-days. Ninety (28%) courses and 806 (24%) days were judged to be nonadherent to a CDC 12-Step. Inappropriate use was more common with continuation of antibiotics (39%) than with initiation (4%) of therapy. Vancomycin was the most commonly used drug (n = 895 antibiotic-days) of which 284 (32%) days were considered inappropriate. Carbapenems were used less frequently (n = 310 antibiotic-days), and 132 (43%) of these days were inappropriate. Common reasons for nonadherence at the time of continuation included failure to narrow antibiotic coverage after microbiologic results were known and prolonged antibiotic prophylaxis after surgery with chest tube placement., Conclusions: The CDC 12-Step Campaign can be modified for neonatal populations. Inappropriate antibiotic prescribing was common in the study NICUs. Improvement efforts should target antibiotic use 72 hours after initiation, particularly focusing on narrowing therapy and instituting protocols to limit prophylaxis.

Antimicrobial resistance is a growing crisis in healthcare. Various antimicrobial stewardship strategies have been used to control antibiotic use in efforts to reduce antibiotic resistance. We conducted a systematic review of antimicrobial stewardship programs in pediatric settings. Twenty-eight published studies met inclusion criteria. The majority (21 of 28) of studies had positive outcomes, but only 6 measured the impact of interventions on antimicrobial resistance. Prescriber education for a specific diagnosis (eg, otitis media) was the most effective intervention in the outpatient setting. Ancillary laboratory tests (eg, rapid diagnostic assays for viral pathogens) were most effective in the inpatient setting. Most studies had moderate to high risk of bias, mainly because of selection bias, inadequate preintervention data for time series analysis, and contamination between treatment groups. To date, there are a limited number of studies assessing antimicrobial stewardship in pediatric settings and these have heterogeneous study designs. Thus, it is difficult to determine the most effective interventions. Future studies should be designed to overcome the biases encountered in current publications.

BACKGROUND: The absence of consensus for outcomes in pediatric antibiotic trials is a major barrier to research harmonization and clinical translation. We sought to develop expert consensus on study outcomes for clinical trials of children with mild community-acquired pneumonia (CAP). METHODS: Applying the Delphi method, a multispecialty expert panel ranked the importance of various components of clinical response and treatment failure outcomes in children with mild CAP for use in research. During Round 1, panelists suggested additional outcomes in open-ended responses that were added to subsequent rounds of consensus building. For Rounds 2 and 3, panelists were provided their own prior responses and summary statistics for each item in the previous round. The consensus was defined by >70% agreement. RESULTS: The expert panel determined that response to and failure of treatment should be addressed at a median of 3 days after initiation. Complete or substantial improvement in fever, work of breathing, dyspnea, tachypnea when afebrile, oral intake, and activity should be included as components of adequate clinical response outcomes. Clinical signs and symptoms including persistent or worsening fever, work of breathing, and reduced oral intake should be included in treatment failure outcomes. Interventions including receipt of parenteral fluids, supplemental oxygen, need for high-flow nasal cannula oxygen therapy, and change in prescription of antibiotics should also be considered in treatment failure outcomes. CONCLUSIONS: Clinical response and treatment failure outcomes determined by the consensus of this multidisciplinary expert panel can be used for pediatric CAP studies to provide objective data translatable to clinical practice.