التفاصيل البيبلوغرافية
العنوان: |
Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia The CAP-IT Randomized Clinical Trial |
المؤلفون: |
Bielicki, JA, Stöhr, W, Barratt, S, Dunn, D, Naufal, N, Roland, D, Sturgeon, K, Finn, A, Rodriguez-Ruiz, JP, Malhotra-Kumar, S, Powell, C, Faust, SN, Alcock, AE, Hall, D, Robinson, G, Hawcutt, DB, Lyttle, MD, Gibb, DM, Sharland, M, PERUKI, GAPRUKI, and the CAP-IT Trial Group, . |
المصدر: |
JAMA , 326 (17) pp. 1713-1724. (2021) |
سنة النشر: |
2021 |
المجموعة: |
University College London: UCL Discovery |
الوصف: |
IMPORTANCE: The optimal dose and duration of oral amoxicillin for children with community-acquired pneumonia (CAP) are unclear. OBJECTIVE: To determine whether lower-dose amoxicillin is noninferior to higher dose and whether 3-day treatment is noninferior to 7 days. DESIGN, SETTINGS AND PARTICIPANTS: Multicenter, randomized, 2 × 2 factorial noninferiority trial enrolling 824 children, aged 6 months and older, with clinically diagnosed CAP, treated with amoxicillin on discharge from emergency departments and inpatient wards of 28 hospitals in the UK and 1 in Ireland between February 2017 and April 2019, with last trial visit on May 21, 2019. INTERVENTIONS: 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). MAIN OUTCOMES AND MEASURES: The primary outcome was clinically indicated antibiotic re-treatment for respiratory infection within 28 days after randomization. The noninferiority margin was 8%. Secondary outcomes included severity/duration of 9 parent-reported CAP symptoms, 3 antibiotic-related adverse events, and phenotypic resistance in colonizing Streptococcus pneumoniae isolates. RESULTS: Of 824 participants randomized into 1 of the 4 groups, 814 received at least 1 dose of trial medication (median [IQR] age, 2.5 years [1.6-2.7]; 421 [52%] males and 393 [48%] females), and the primary outcome was available for 789 (97%). For lower vs higher dose, the primary outcome occurred in 12.6% with lower dose vs 12.4% with higher dose (difference, 0.2% [1-sided 95% CI –∞ to 4.0%]), and in 12.5% with 3-day treatment vs 12.5% with 7-day treatment (difference, 0.1% [1-sided 95% CI –∞ to 3.9]). Both groups demonstrated noninferiority with no significant interaction between dose and duration (P = .63). Of the 14 prespecified secondary end points, the only significant differences were 3-day vs 7-day treatment for cough duration (median 12 days vs 10 days; ... |
نوع الوثيقة: |
article in journal/newspaper |
اللغة: |
English |
العلاقة: |
https://discovery.ucl.ac.uk/id/eprint/10138217Test/ |
الإتاحة: |
https://discovery.ucl.ac.uk/id/eprint/10138217Test/ |
حقوق: |
open |
رقم الانضمام: |
edsbas.936E46BD |
قاعدة البيانات: |
BASE |