Evidence map›Paper›PMID 34189338›Full record

ArticleContemporary clinical trials communications2021

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

Mythili Srinivasan, Leonard B Bacharier, Charles W Goss, Yanjiao Zhou, Jonathan Boomer, Sarah Bram, Dana Burgdorf, Carey-Ann Burnham, Timothy Casper, Mario Castro and 13 more

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Childhood Asthma: Is It All About Bacteria and Not About Viruses? A Pro/Con Debate.The journal of allergy and clinical immunology. In practice
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 2 institutions in 1 country.

Mythili SrinivasanDivision of Hospitalist Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Leonard B BacharierDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Charles W GossDivision of Biostatistics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Yanjiao ZhouDepartment of Medicine, University of Connecticut School of Medicine, Farmington, CT, USA.
Jonathan BoomerDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Sarah BramDivision of Hospitalist Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Dana BurgdorfDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Carey-Ann BurnhamDepartment of Pathology and Immunology, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, CAB, USA.
Timothy CasperDivision of Hospitalist Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Mario CastroDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Andrea CoverstoneDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Matthew HaslamDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Watcharoot KanchongkittiphonDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Cadence KuklinskiDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Qinghua LianDivision of Biostatistics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Kenneth SchechtmanDivision of Biostatistics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Gregory A StorchDivision of Pediatric Infectious Disease, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Kelly TrueDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Meghan A WallaceDepartment of Pathology and Immunology, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, CAB, USA.
Huiqing Yin-DeClueDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Elizabeth AhrensDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Jinli WangDivision of Biostatistics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Avraham BeigelmanDivision of Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, 660 S. Euclid Ave, St. Louis, MO, 63110, USA.
Washington University in St. Louis · USUniversity of Connecticut · US

Funding

AZITHROMYCIN TO PREVENT RECURRENT WHEEZING FOLLOWING SEVERE RSV BRONCHIOLITISR01HL130876 · NHLBI · WASHINGTON UNIVERSITY · PI BACHARIER, LEONARD B, BEIGELMAN, AVRAHAM · 2016 to 2020
$3.7M
NHLBI NIH HHS R01 HL130876
6 · The paper itself

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.

Indexed as

AE, Adverse eventsAESI, AEs of Special InterestAPW, Azithromycin to Prevent WheezingAsthmaAzithromycinAZM, AzithromycinDSMB, Data safety and monitoring boardED, Emergency departmentICS, Inhaled corticosteroidsIL, InterleukinIRB, Institutional review boardLRTI, Lower respiratory tract infectionMicrobiomeMMP-9, Matrix metallopeptidase-9NHLBI, National Heart, Lung, and Blood InstitutePC, Phone callRBEL, RSV Bronchiolitis in Early LifeRecurrent wheezingRespiratory syncytial virus (RSV) bronchiolitisRSV, Respiratory syncytial virusRW, Recurrent wheezingRZ, RandomizationSAE, serious adverse eventsSLCH, Saint Louis Children's HospitalV, visit

Identifiers

PMID34189338
PMCPMC8219746
OpenAlexW3168875279

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.