The azithromycin to prevent wheezing following severe RSV bronchiolitis-II clinical trial: Rationale, study design, methods, and characteristics of study population
| Autor: | 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, Yanjiao Zhou |
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| Rok vydání: | 2020 |
| Předmět: |
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 |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 22, Iss, Pp 100798-(2021) |
| ISSN: | 2451-8654 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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