Division of Infectious Diseases, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
Pediatric Emergency Research Canada, Calgary, Alberta, Canada.
JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.
IMPORTANCE: Community-acquired pneumonia (CAP) is a common occurrence in childhood; consequently, evidence-based recommendations for its treatment are required. OBJECTIVE: To determine whether 5 days of high-dose amoxicillin for CAP was associated with noninferior rates of clinical cure compared with 10 days of high-dose amoxicillin. DESIGN, SETTING, AND PARTICIPANTS: The SAFER (Short-Course Antimicrobial Therapy for Pediatric Respiratory Infections) study was a 2-center, parallel-group, noninferiority randomized clinical trial consisting of a single-center pilot study from December 1, 2012, to March 31, 2014, and the follow-up main study from August 1, 2016, to December 31, 2019 at the emergency departments of McMaster Children's Hospital and the Children's Hospital of Eastern Ontario. Research staff, participants, and outcome assessors were blinded to treatment allocation. Eligible children were aged 6 months to 10 years and had fever within 48 hours, respiratory symptoms, chest radiography findings consistent with pneumonia as per the emergency department physician, and a primary diagnosis of pneumonia. Children were excluded if they required hospitalization, had comorbidities that would predispose them to severe disease and/or pneumonia of unusual origin, or had previous β-lactam antibiotic therapy. Data were analyzed from March 1 to July 8, 2020. INTERVENTIONS: Five days of high-dose amoxicillin therapy followed by 5 days of placebo (intervention group) vs 5 days of high-dose amoxicillin followed by a different formulation of 5 days of high-dose amoxicillin (control group). MAIN OUTCOMES AND MEASURES: Clinical cure at 14 to 21 days. RESULTS: Among the 281 participants, the median age was 2.6 (interquartile range, 1.6-4.9) years (160 boys [57.7%] of 279 with sex listed). Clinical cure was observed in 101 of 114 children (88.6%) in the intervention group and in 99 of 109 (90.8%) in the control group in per-protocol analysis (risk difference, -0.016; 97.5% confidence limit, -0.087). Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061). CONCLUSIONS AND RELEVANCE: Short-course antibiotic therapy appeared to be comparable to standard care for the treatment of previously healthy children with CAP not requiring hospitalization. Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02380352.
重要性：社区获得性肺炎（CAP）在儿童中很常见；因此，需要有循证推荐的治疗方法。 目的：确定 5 天高剂量阿莫西林治疗 CAP 的临床治愈率是否与 10 天高剂量阿莫西林相当。 设计、地点和参与者：SAFER（儿科呼吸道感染短期抗菌治疗）研究是一项 2 中心、平行组、非劣效性随机临床试验，包括 2012 年 12 月 1 日至 2014 年 3 月 31 日的单中心试点研究和 2016 年 8 月 1 日至 2019 年 12 月 31 日的后续主要研究，地点为麦克马斯特儿童医院和东安大略儿童医院的急诊科。研究人员、参与者和结果评估者对治疗分配均不知情。符合条件的儿童年龄在 6 个月至 10 岁之间，发热在 48 小时内，有呼吸道症状，根据急诊科医生的检查结果有符合肺炎的胸部影像学表现，且主要诊断为肺炎。如果需要住院、有使疾病恶化和/或肺炎来源不寻常的合并症、或有过β-内酰胺类抗生素治疗的儿童被排除在外。数据于 2020 年 3 月 1 日至 7 月 8 日进行分析。 干预措施：5 天高剂量阿莫西林治疗后加用 5 天安慰剂（干预组）或 5 天高剂量阿莫西林治疗后加用不同配方的 5 天高剂量阿莫西林（对照组）。 主要结局和测量指标：14 至 21 天的临床治愈率。 结果：在 281 名参与者中，中位年龄为 2.6 岁（四分位距，1.6-4.9 岁）（279 名列出性别的儿童中 160 名男孩[57.7%]）。意向治疗分析中，干预组 114 名儿童中有 101 名（88.6%）和对照组 109 名儿童中有 99 名（90.8%）在 14 至 21 天达到临床治愈（风险差异，-0.016；97.5%置信区间，-0.087）。在 14 至 21 天达到临床治愈的儿童中，干预组 126 名中有 108 名（85.7%）和对照组 126 名中有 106 名（84.1%）在方案治疗分析中（风险差异，0.023；97.5%置信区间，-0.061）。 结论和相关性：短期抗生素治疗似乎与标准治疗相当，可用于治疗不需要住院的健康儿童的 CAP。临床实践指南应考虑根据抗菌药物管理原则推荐 5 天阿莫西林用于儿科肺炎管理。 试验注册：ClinicalTrials.gov 标识符：NCT02380352。
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