Critical revision of the manuscript for important intellectual content: Bielicki, Stöhr, Barratt, Dunn, Naufal, Roland, Finn, Rodriguez Ruiz, Malhotra-Kumar, Powell, Faust, Alcock, Hall, Robinson, Hawcutt, Lyttle, Sharland. Most importantly, a shorter course (three days) of amoxicillin treatment is as good as longer treatment courses, for the majority of children being discharged from hospital with CAP. Short-course antimicrobial therapy for pediatric community-acquired pneumonia: the SAFER randomized clinical trial. Role of the Funder/Sponsor: The NIHR had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Children were randomized 1:1 to receive oral amoxicillin at a lower dose (35-50 mg/kg/d; n = 410) or higher dose (70-90 mg/kg/d; n = 404), for a shorter duration (3 days; n = 413) or a longer duration (7 days; n = 401). Shamim MA, Padhi BK, Satapathy P, Siddiq A, Manna S, Aggarwal AK, Al-Ahdal T, Khubchandani J, Henao-Martinez AF, Sah R. This was a multicenter, randomized, blinded, placebo-controlled, 2 × 2 factorial, noninferiority trial conducted in 28 hospitals in the UK and 1 in Ireland, comparing total daily amoxicillin dose (35-50 mg/kg or 70-90 mg/kg) and duration (3 or 7 days) for treatment of childhood CAP.The trial was designed to demonstrate noninferiority of lower dose compared with higher dose, and shorter duration compared with longer duration, in terms of the primary end point. For binary clinical end points, a noninferiority margin of up to 20% could be acceptable per the Infectious Diseases Society of America. Primary care physicians were asked about nontrial antibiotic prescriptions if the 28-day visit was missed, provided written consent had been given. CAP-IT found that a shorter duration of treatment of 3 days of amoxicillin was as good as a longer duration of 7 days in terms of children not needing further antibiotic treatment within 4 weeks. Cap-It™ is our recyclable paperboard clip alternative to shrink film and other plastic packaging, that works for PET bottles with neck rings.

Results Of 824 participants randomized into 1 of the 4 groups, 814 received at least 1 dose of trial medication (median [IQR] age, 2. Participants were randomised into one of four study groups (low dose/short duration; low dose/long duration; high dose/short duration; high dose/long duration) at a 1:1 ratio. We provide computer services to companies who require our help, advice and expertise across the wide scope of IT. In total, 43 (5%) children experienced a serious adverse event; all were hospitalizations, and most (37 [86%]) were due to respiratory illness ( Table 3; and eTable 9 in Supplement 2). Neither chest radiographs nor inflammatory biomarkers differentiate which children with CAP require antibiotics.Question For children with community-acquired pneumonia discharged from an emergency department, observational unit, or inpatient ward (within 48 hours), is subsequent outpatient treatment with oral amoxicillin at a dose of 35 to 50 mg/kg per day noninferior to 70 to 90 mg/kg per day, and is a 3-day course noninferior to 7 days, with regard to the need for antibiotic re-treatment? Ten children received no trial medication and were excluded from the analysis, resulting in an analysis population of 814. Given a 15% antibiotic re-treatment rate based on internal pilot data, 15% loss to follow-up, and assuming no interaction between the dose and duration interventions, the sample size of 800 participants was estimated to achieve 90% power. Analyses of primary and secondary end points were to be based on observed data only taking into account information across all visits, with multiple imputation to be considered if data were missing for more than 10% of participants. Both groups demonstrated noninferiority with no significant interaction between dose and duration (P = .

Trial steering committee independent members: Elizabeth Molyneux (chair), MD, College of Medicine, Blantyre, Malawi; Chris Butler, MD, University of Oxford, Oxford, UK; Alan Smyth, MD, University of Nottingham, Nottingham, UK; and Catherine Prichard, BSc, patient representative. Duration of cough was longer for the patients randomised to shorter treatment (12 days, compared to 10 for the longer treatment regime).The data and safety monitoring committee, with support from the trial steering committee, recommended the following amendments: (1) joint analysis of children immediately discharged from the ED and discharged after an inpatient stay (eMethods 5 in Supplement 2); and (2) revision of the noninferiority margin from 4% to 8% to be closer to the most conservative 10% noninferiority margin recommended by the Infectious Diseases Society of America for noninferiority trials in CAP with a mortality end point (eMethods 6 in Supplement 2).