The azithromycin to prevent wheezing following severe RSV bronchiolitis-II clinical trial: Rationale, study design, methods, and characteristics of study population

Contemporary Clinical Trials Communications

Leonard B. Bacharier¹  Jonathan Boomer²  Huiqing Yin-DeClue³  Timothy Casper³  Carey-Ann Burnham⁴  Cadence Kuklinski⁴  Meghan A. Wallace⁴  Jinli Wang⁴  Charles W. Goss⁴  Matthew Haslam⁴  Watcharoot Kanchongkittiphon⁴  Qinghua Lian⁴  Avraham Beigelman⁵  Gregory A. Storch⁵  Kenneth Schechtman⁵  Yanjiao Zhou⁵  Mythili Srinivasan⁶  Mario Castro⁶  Dana Burgdorf⁶  Kelly True⁷  Andrea Coverstone⁸  Elizabeth Ahrens⁸  Sarah Bram⁸ 

[1] Corresponding author.;Department of Medicine, University of Connecticut School of Medicine, Farmington, CT, USA;Department of Pathology and Immunology, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, CAB, USA;Division of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA;Division of Biostatistics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA;Division of Hospitalist Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA;Division of Pediatric Infectious Disease, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA;Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA;

关键词: Respiratory syncytial virus (RSV) bronchiolitis;    Azithromycin;    Recurrent wheezing;    Asthma;    Microbiome;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown