IMPORTANCE Childhood community-acquired pneumonia (CAP) is usually treated with 10 days of antibiotics. Shorter courses may be effective with fewer adverse effects and decreased potential for antibiotic resistance. OBJECTIVE To compare a short (5-day) vs standard (10-day) antibiotic treatment strategy for CAP in young children. DESIGN, SETTING, AND PARTICIPANTS Randomized double-blind placebo-controlled clinical trial in outpatient clinic, urgent care, or emergency settings in 8 US cities. A total of 380 healthy children aged 6 to 71 months with nonsevere CAP demonstrating early clinical improvement were enrolled from December 2, 2016, to December 16, 2019. Data were analyzed from January to September 2020. INTERVENTION On day 6 of their originally prescribed therapy, participants were randomized 1:1 to receive 5 days of matching placebo or 5 additional days of the same antibiotic. MAIN OUTCOMES AND MEASURES The primary end point was the end-of-treatment response adjusted for duration of antibiotic risk (RADAR), a composite end point that ranks each child's clinical response, resolution of symptoms, and antibiotic-associated adverse effects in an ordinal desirability of outcome ranking (DOOR). Within each DOOR rank, participants were further ranked by the number of antibiotic days, assuming that shorter antibiotic durations were more desirable. Using RADAR, the probability of a more desirable outcome was estimated for the short- vs standard-course strategy. In a subset of children, throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. RESULTS A total of 380 children (189 randomized to short course and 191 randomized to standard course) made up the study population. The mean (SD) age was 35.7 (17.2) months, and 194 participants (51%) were male. Of the included children, 8 were Asian, 99 were Black or African American, 234 were White, 32 were multiracial, and 7 were of unknown or unreported race; 33 were Hispanic or Latino, 344 were not Hispanic or Latino, and 3 were of unknown or unreported ethnicity. There were no differences between strategies in the DOOR or its individual components. Fewer than 10% of children in either strategy had an inadequate clinical response. The short-course strategy had a 69% (95% CI, 63-75) probability of a more desirable RADAR outcome compared with the standard-course strategy. A total of 171 children were included in the resistome analysis. The median (range) number of antibiotic resistance genes per prokaryotic cell (RGPC) was significantly lower in the short-course strategy compared with the standard-course strategy for total RGPC (1.17 [0.35-2.43] vs 1.33 [0.46-11.08]; P = .01) and β-lactamase RGPC (0.55 [0.18-1.24] vs 0.60 [0.21-2.45]; P = .03). CONCLUSIONS AND RELEVANCE In this study, among children responding to initial treatment for outpatient CAP, a 5-day antibiotic strategy was superior to a 10-day strategy. The shortened approach resulted in similar clinical response and antibiotic-associated adverse effects, while reducing antibiotic exposure and resistance. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02891915.

中文翻译：

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儿童社区获得性肺炎的短期与标准疗程门诊抗生素治疗：SCOUT-CAP 随机临床试验。

重要性 儿童社区获得性肺炎 (CAP) 通常使用 10 天的抗生素治疗。较短的疗程可能是有效的，副作用更少，抗生素耐药性的可能性降低。目的 比较针对幼儿 CAP 的短期（5 天）与标准（10 天）抗生素治疗策略。设计、地点和参与者 在美国 8 个城市的门诊、紧急护理或紧急情况下进行的随机双盲安慰剂对照临床试验。从 2016 年 12 月 2 日到 2019 年 12 月 16 日，共有 380 名年龄在 6 至 71 个月的非重度 CAP 健康儿童被纳入，这些儿童表现出早期临床改善。分析了 2020 年 1 月至 2020 年 9 月的数据。干预 在他们最初规定的治疗的第 6 天, 参与者被随机分配 1: 1 接受 5 天的匹配安慰剂或 5 天的相同抗生素。主要结果和测量 主要终点是根据抗生素风险持续时间调整的治疗结束反应 (RADAR)，这是一个复合终点，按顺序对每个儿童的临床反应、症状缓解和抗生素相关不良反应进行排名结果排名（DOOR）的可取性。在每个 DOOR 排名中，参与者根据抗生素天数进一步排名，假设更短的抗生素持续时间更可取。使用 RADAR，可以估计短期课程与标准课程策略获得更理想结果的可能性。在研究的第 19 天和第 25 天之间收集了一部分儿童的咽拭子，以量化口咽菌群中的抗生素抗性基因。结果 研究人群共有 380 名儿童（189 名随机分配到短期课程，191 名随机分配到标准课程）。平均 (SD) 年龄为 35.7 (17.2) 个月，194 名参与者 (51%) 为男性。在纳入的儿童中，8 人是亚裔，99 人是黑人或非裔美国人，234 人是白人，32 人是混血儿，7 人是未知或未报告的种族；33 人是西班牙裔或拉丁裔，344 人不是西班牙裔或拉丁裔，3 人是未知或未报告的种族。DOOR 或其各个组件中的策略之间没有差异。在这两种策略中，只有不到 10% 的儿童临床反应不充分。与标准课程策略相比，短期课程策略有 69%（95% CI，63-75）的概率获得更理想的 RADAR 结果。共有 171 名儿童被纳入耐药组分析。与总 RGPC 的标准疗程策略相比，短期策略中每个原核细胞 (RGPC) 的抗生素抗性基因中位数（范围）数量显着降低（1.17 [0.35-2.43] 对 1.33 [0.46-11.08]； P = .01) 和 β-内酰胺酶 RGPC（0.55 [0.18-1.24] 对比 0.60 [0.21-2.45]；P = .03）。结论和相关性 在这项研究中，在对门诊 CAP 初始治疗有反应的儿童中，5 天抗生素策略优于 10 天策略。缩短的方法导致类似的临床反应和抗生素相关的不良反应，同时减少抗生素暴露和耐药性。试验注册 ClinicalTrials.gov 标识符：NCT02891915。