Rationale: People with cystic fibrosis (CF) experience acute worsening of respiratory symptoms and lung function known as pulmonary exacerbations. Treatment with intravenous antimicrobials is common; however, there is scant evidence to support a standard treatment duration. Objectives: To test differing durations of intravenous antimicrobials for CF exacerbations. Methods: STOP2 (Standardized Treatment of Pulmonary Exacerbations 2) was a multicenter, randomized, controlled clinical trial in exacerbations among adults with CF. After 7-10 days of treatment, participants exhibiting predefined lung function and symptom improvements were randomized to 10 or 14 days' total antimicrobial duration; all others were randomized to 14 or 21 days' duration. Measurements and Main Results: The primary outcome was percent predicted FEV1 (ppFEV1) change from treatment initiation to 2 weeks after cessation. Among early responders, noninferiority of 10 days to 14 days was tested; superiority of 21 days compared with 14 days was compared for the others. Symptoms, weight, and adverse events were secondary. Among 982 randomized people, 277 met improvement criteria and were randomized to 10 or 14 days of treatment; the remaining 705 received 21 or 14 days of treatment. Mean ppFEV1 change was 12.8 and 13.4 for 10 and 14 days, respectively, a ‒0.65 difference (95% CI [‒3.3 to 2.0]), excluding the predefined noninferiority margin. The 21- and 14-day arms experienced 3.3 and 3.4 mean ppFEV1 changes, a difference of ‒0.10 (‒1.3 to 1.1). Secondary endpoints and sensitivity analyses were supportive. Conclusions: Among adults with CF with early treatment improvement during exacerbation, ppFEV1 after 10 days of intravenous antimicrobials is not inferior to 14 days. For those with less improvement after one week, 21 days is not superior to 14 days. Clinical trial registered with www.clinicaltrials.gov (NCT02781610).

中文翻译：

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囊性纤维化肺部恶化治疗的抗菌持续时间的随机临床试验。

理由：患有囊性纤维化 (CF) 的人会经历呼吸道症状和肺功能的急性恶化，称为肺部恶化。静脉注射抗菌药物治疗很常见；然而，支持标准治疗持续时间的证据不足。目的：测试不同持续时间的静脉内抗菌药物治疗 CF 恶化。方法：STOP2（肺部恶化的标准化治疗 2）是一项针对成人 CF 恶化的多中心、随机、对照临床试验。治疗 7-10 天后，表现出预定肺功能和症状改善的参与者被随机分配到 10 或 14 天的总抗菌持续时间；所有其他人被随机分配到 14 或 21 天的持续时间。测量和主要结果：主要结果是从治疗开始到停止后 2 周的预计 FEV1 (ppFEV1) 变化百分比。在早期反应者中，测试了 10 天至 14 天的非劣效性；与其他人相比，21 天优于 14 天。症状、体重和不良事件是次要的。在 982 名随机分组的人中，277 人符合改善标准并被随机分配到 10 或 14 天的治疗；其余 705 人接受了 21 或 14 天的治疗。10 天和 14 天的平均 ppFEV1 变化分别为 12.8 和 13.4，差异为 ∼0.65（95% CI [∼3.3 至 2.0]），不包括预定义的非劣效性界值。21 天和 14 天的组经历了 3.3 和 3.4 的平均 ppFEV1 变化，差异为 ‒0.10（‒1.3 至 1.1）。次要终点和敏感性分析是支持性的。结论：在急性加重期间早期治疗改善的 CF 成人中，静脉注射抗生素 10 天后的 ppFEV1 不劣于 14 天。对于一周后改善较少的人，21 天并不优于 14 天。在 www.clinicaltrials.gov (NCT02781610) 注册的临床试验。