1. The azithromycin to prevent wheezing following severe RSV bronchiolitis-II clinical trial: Rationale, study design, methods, and characteristics of study population
- Author
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Dana Burgdorf, Charles W. Goss, Elizabeth Ahrens, Cadence A. Kuklinski, Qinghua Lian, Kelly True, Mythili Srinivasan, Kenneth B. Schechtman, Matthew Haslam, Avraham Beigelman, Timothy J Casper, Sarah Bram, Gregory A. Storch, Carey-Ann D. Burnham, Huiqing Yin-Declue, Meghan A. Wallace, Jonathan S. Boomer, Jinli Wang, Mario Castro, Watcharoot Kanchongkittiphon, Leonard B. Bacharier, Andrea M. Coverstone, and Yanjiao Zhou
- Subjects
AESI, AEs of Special Interest ,Medicine (General) ,Pediatrics ,AE, Adverse events ,Azithromycin ,law.invention ,0302 clinical medicine ,RBEL, RSV Bronchiolitis in Early Life ,Randomized controlled trial ,law ,ED, Emergency department ,Medicine ,IL, Interleukin ,030212 general & internal medicine ,DSMB, Data safety and monitoring board ,General Medicine ,respiratory system ,Respiratory syncytial virus (RSV) bronchiolitis ,SAE, serious adverse events ,Population study ,RSV, Respiratory syncytial virus ,medicine.drug ,NHLBI, National Heart, Lung, and Blood Institute ,RZ, Randomization ,medicine.medical_specialty ,PC, Phone call ,IRB, Institutional review board ,Placebo ,Article ,ICS, Inhaled corticosteroids ,03 medical and health sciences ,R5-920 ,MMP-9, Matrix metallopeptidase-9 ,APW, Azithromycin to Prevent Wheezing ,Asthma ,Pharmacology ,RW, Recurrent wheezing ,business.industry ,LRTI, Lower respiratory tract infection ,medicine.disease ,AZM, Azithromycin ,SLCH, Saint Louis Children's Hospital ,Clinical trial ,Recurrent wheezing ,Bronchiolitis ,Observational study ,V, visit ,Microbiome ,business ,030217 neurology & neurosurgery - 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.
- Published
- 2020