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Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II (APW-RSV-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Avraham Beigelman, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02911935
First received: September 18, 2016
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
The main objective of the APW-RSV II clinical trial is to evaluate if the addition of azithromycin to routine bronchiolitis care, among infants hospitalized with RSV bronchiolitis, reduces the occurrence of recurrent wheeze during the preschool years.

Condition Intervention Phase
Respiratory Syncytial Virus, Bronchiolitis
Drug: Oral azithromycin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The occurrence of a third episode of post-RSV wheezing [ Time Frame: Follow up duration of 18-48 months ]
    The time until the occurrence of a third episode of post-RSV wheezing measured over a follow up duration of 18-48 months, quantified by a Cox proportional hazards regression model


Secondary Outcome Measures:
  • Physician diagnosis of asthma [ Time Frame: Follow up duration of 18-48 months ]
    Time to physician asthma diagnosis

  • Days with respiratory symptoms (wheezing, cough, or shortness of breath), or albuterol use [ Time Frame: Follow up duration of 18-48 months ]
    Annualized number of days with: any respiratory symptoms (wheezing, cough, or shortness of breath), or albuterol use

  • Oral Corticosteroid Use [ Time Frame: Follow up duration of 18-48 months ]
    The rate of oral corticosteroid courses use

  • Antibiotic Use [ Time Frame: Follow up duration of 18-48 months ]
    The rate of antibiotic courses use

  • Severe Adverse Events [ Time Frame: Follow up duration of 18-48 months ]
    Rates of severe adverse events

  • The occurrence of a third episode of post-RSV wheezing OR asthma diagnosis [ Time Frame: Follow up duration of 18-48 months ]
    The time to the third episode of post-RSV wheezing OR to asthma diagnosis


Estimated Enrollment: 188
Study Start Date: November 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral azithromycin
Oral Azithromycin
Drug: Oral azithromycin
Oral azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
Other Name: Azithromycin suspension
Placebo Comparator: Placebo
Oral Placebo
Drug: Placebo
Placebo suspension

Detailed Description:

The APW-RSV II clinical trial is a double blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy 188 participants, ages 1-18 months, who are hospitalized due to RSV bronchiolitis. The study includes active treatment phase with azithromycin or placebo for 2 weeks, and an observational phase for up to 48 months.

The main objective of the APW-RSV II clinical trial is to evaluate if the addition of azithromycin to routine bronchiolitis care, among infants hospitalized with RSV bronchiolitis, reduces the occurrence of recurrent wheeze (RW) during the preschool years.

Study participants will be enrolled during 3 consecutive RSV seasons beginning in Fall 2016. Study participants will be randomized to receive PO azithromycin 10 mg/kg/day for 7 days followed by 5mg/kg/day for additional 7 days, or matched placebo. The primary clinical outcome is the time to the occurrence of a third episode of wheezing. The duration of follow up is 18-48 months, which is determined based on the year in which the participants is recruited: first year recruits will be followed for up to 48 months, while the 3rd year recruits will be followed for at least 18 months.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 1-18 months.
  • Hospitalization for the first episode of RSV bronchiolitis.
  • Confirmed RSV infection by positive nasal swab results (PCR assay and/or direct antigen detection).
  • At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions)28.
  • Duration of respiratory symptoms from onset of symptoms of the current illness to admission is 120 hours (5 days) or less.
  • Randomization can be performed within 168 hours (7 days) from onset of symptoms.
  • Willingness to provide informed consent by the child's parent or guardian.

Exclusion Criteria:

  • Prematurity (gestational age < 36 weeks).
  • Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis and/or food allergy will not be excluded from the study.
  • Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
  • The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
  • History of previous (before the current episode) wheeze or previous (before the current episode) treatment with albuterol.
  • History of previous treatment with corticosteroid (systemic or inhaled) for respiratory issues.
  • Treatment (past or present) with montelukast.
  • Treatment with any macrolide antibiotic (azithromycin, clarithromycin or erythromycin) over the past 4 weeks or current treatment with any macrolide antibiotic. Current or prior treatment with non-macrolide antibiotic is not an exclusion criterion.
  • Chronic treatment with any daily medication other than vitamins or nutritional supplements. Although routine vitamin D supplement (400 IU per day) is not an exclusion criterion, high dose vitamin D supplements are not allowed.
  • Participation in another clinical trial.
  • Participant requires invasive mechanical ventilation due to RSV bronchiolitis.
  • Evidence that the family may be unreliable or non-adherent, or has definitive plans to move from the clinical center area before trial completion.
  • Contraindication of use of azithromycin or any other macrolide antibiotics such as history of allergic reaction (or other adverse reaction) to these antibiotics.
  • Diagnosis of asthma.
  • Treatment with other medication that may cause QT interval prolongation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02911935

Contacts
Contact: Avraham Beigelman, MD, MSCI beigelman_a@kids.wustl.edu
Contact: Dana Burgdorf, BS, MBA burgdorf_d@kids.wustl.edu

Locations
United States, Missouri
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Avraham Beigelman, MD       beigelman_a@kids.wustl.edu   
Principal Investigator: Avraham Beigelman, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Avraham Beigelman, MD, MSCI Washington University School of Medicine
  More Information

Responsible Party: Avraham Beigelman, Associate Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02911935     History of Changes
Other Study ID Numbers: 201603018
Study First Received: September 18, 2016
Last Updated: May 15, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Sounds
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017