- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911935
Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II (APW-RSV-II)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Oral Placebo
|
Placebo suspension
|
Active Comparator: Oral azithromycin
Oral Azithromycin
|
Oral azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experienced the Occurrence of a Third Episode of Post-RSV Wheezing (Recurrent Wheeze)
Time Frame: Follow up duration of 18-48 months
|
Episodes of wheezing were captured at each of the study telephone interviews and clinic visits using the question, "Has your child's chest sounded wheezy or whistling (with and without a cold)?".
A new wheezing episode was defined if at least 7 days without wheezing had been reported since the previous episode.
|
Follow up duration of 18-48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Had Physician Asthma Diagnosis
Time Frame: Follow up duration of 18-48 months
|
Physician asthma diagnosis were captured at each of the study telephone interviews and clinic visits using the question, "Has the doctor told you that your child has asthma?".
|
Follow up duration of 18-48 months
|
Annualized Number of Days With Respiratory Symptoms (Wheezing, Cough, or Shortness of Breath)
Time Frame: Follow up duration of 18-48 months
|
The number of days with respiratory symptoms were captured during clinic visits and by telephone interviews every other month using two questions, "Does your child have coughing, wheezing, shortness of breath or chest tightness during the daytime?", "If yes, estimate the number of days".
We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
|
Follow up duration of 18-48 months
|
Annualized Number of Days With Albuterol Use
Time Frame: Follow up duration of 18-48 months
|
The number of days with albuterol use were captured during clinic visits and by telephone interviews every other month using two questions, "Has your child taken Albuterol (also known as Ventolin, Pro-air, Proventil)?" and "please estimate # of days your child had albuterol treatments since the last visit".
We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
|
Follow up duration of 18-48 months
|
Annualized Number of Oral Corticosteroid Courses
Time Frame: Follow up duration of 18-48 months
|
The number of oral corticosteroid courses were captured during clinic visits and by telephone interviews every other month using two questions, "Has your child taken Oral steroids (Prednisone, Prednisolone, Orapred, Dexamethasone)?" and "how many separate courses of steroids has your child had since the last visit?".
We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
|
Follow up duration of 18-48 months
|
Annualized Number of Antibiotic Courses
Time Frame: Follow up duration of 18-48 months
|
The number of antibiotic courses were captured during clinic visits and by telephone interviews every other month using two questions, "Has your child taken any antibiotics?"
and "How many separate prescriptions has your child taken of an antibiotic(s)?".
We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
|
Follow up duration of 18-48 months
|
Number of Participants Who Experienced Serious Adverse Events
Time Frame: Follow up duration of 18-48 months
|
Serious Adverse Event were captured during clinic visits and by telephone interviews every other month using designed SAE form.
|
Follow up duration of 18-48 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Avraham Beigelman, MD, MSCI, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201603018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers may request access to study documents, including the study protocol with any amendments and blank case report forms.
Upon reasonable request, these data will be provided by Dr. Charles Goss, the study statistician. email: cwgoss@wustl.edu
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Syncytial Virus, Bronchiolitis
-
Hannover Medical SchoolRecruitingRespiratory Syncytial Virus Infections | Respiratory Syncytial Virus (RSV) | Respiratory Syncytial Virus-bronchiolitisGermany
-
Hospices Civils de LyonUnknownRespiratory Syncytial Virus Infections | RSV Infection | Syncytial Virus Respiratory Infection | RSV Bronchiolitis
-
Hospital of South West JutlandCompletedRespiratory Syncytial Virus BronchiolitisDenmark
-
Hamad Medical CorporationCompleted
-
University Hospitals, LeicesterPediatric Emergency Research in the UK and Ireland (PERUKI); Respiratory syncytial...RecruitingBronchiolitis; Respiratory Syncytial VirusUnited Kingdom
-
Assiut UniversityUnknownBronchiolitis; Respiratory Syncytial Virus
-
Organon and CoCompletedRespiratory Syncytial Virus Bronchiolitis
-
Combined Military Hospital, PakistanRecruitingAcute Bronchiolitis Due to Respiratory Syncytial VirusPakistan
-
VirometixCenter of Vaccinology, Ghent, Belgium (CEVAC); Expert Clinical Services Organization...CompletedAcute Bronchiolitis Due to Respiratory Syncytial VirusBelgium
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States