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Abstract：
Severe respiratory syncytial virus (RSV) bronchiolitis in early life is a significant risk factor for future recurrent wheeze (RW) and asthma. The goal of the Azithromycin to Prevent Wheezing following severe RSV bronchiolitis II (APW-RSV II) clinical trial is to evaluate if azithromycin treatment in infants hospitalized with RSV bronchiolitis reduces the occurrence of RW during the preschool years. The APW-RSV II clinical trial is a double-blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy participants, ages 30 days-18 months, who are hospitalized due to RSV bronchiolitis. The study includes an active randomized treatment phase with azithromycin or placebo for 2 weeks, and an observational phase of 18-48 months. Two hundred participants were enrolled during three consecutive RSV seasons beginning in the fall of 2016 and were randomized to receive oral azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for an additional 7 days, or matched placebo. The study hypothesis is that in infants hospitalized with RSV bronchiolitis, the addition of azithromycin therapy to routine bronchiolitis care would reduce the likelihood of developing post-RSV recurrent wheeze (≥3 episodes). The primary clinical outcome is the occurrence of a third episode of wheezing, which is evaluated every other month by phone questionnaires and during yearly in-person visits. A secondary objective of the APW-RSV II clinical trial is to examine how azithromycin therapy changes the upper airway microbiome composition, and to determine if these changes are related to the occurrence of post-RSV RW. Microbiome composition is characterized in nasal wash samples obtained before and after the study treatments. This clinical trial may identify the first effective intervention applied during severe RSV bronchiolitis to reduce the risk of post-RSV RW and ultimately asthma.
摘要：
生命早期的严重呼吸道合胞病毒（RSV）细支气管炎是未来反复喘息（RW）和哮喘的重要危险因素。阿奇霉素预防严重RSV毛细支气管炎II（APW-RSVII）临床试验后喘息的目标是评估RSV毛细支气管炎住院婴儿的阿奇霉素治疗是否可以减少学龄前RW的发生。APW-RSVII临床试验是双盲的,安慰剂对照,平行组，随机试验,包括其他健康的参与者，年龄30天-18个月，因RSV毛细支气管炎住院。该研究包括阿奇霉素或安慰剂2周的积极随机治疗阶段，观察期为18-48个月。从2016年秋季开始，在连续三个RSV季节中招募了200名参与者，并随机接受口服阿奇霉素10mg/kg/天，持续7天，然后是5mg/kg/天，再持续7天。或匹配的安慰剂。研究假设是，在RSV毛细支气管炎住院的婴儿中，在常规毛细支气管炎治疗中加入阿奇霉素治疗可降低RSV后复发性喘息(≥3次)的可能性.主要临床结果是发生第三次喘息，每隔一个月通过电话问卷和每年的面对面访问进行评估。APW-RSVII临床试验的次要目标是检查阿奇霉素治疗如何改变上呼吸道微生物组组成，并确定这些变化是否与RSV后RW的发生有关。在研究处理之前和之后获得的鼻洗样品中表征微生物组组合物。该临床试验可以确定在严重RSV细支气管炎期间应用的第一个有效干预措施，以降低RSVRW后和最终哮喘的风险。
