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Respiratory Syncytial Virus, BronchiolitisPhase 2/3APW-RSV-IINCT02911935

Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II

A Phase 2/3 study testing Oral azithromycin in people with Respiratory Syncytial Virus, Bronchiolitis, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 month to 18 months
What is being tested?
Oral azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited States
Study dates
Nov 2016to Apr 2021
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the 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.

Being tested
Oral azithromycin, Placebo
Medical subject headings
Bronchiolitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral azithromycinDrug

    Also called Azithromycin suspension

    Oral azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days

  • PlaceboDrug

    Placebo suspension

Study groups in NCT02911935
Study groupRoleWhat they receive
Oral azithromycinActive comparatorOral Azithromycin
Receives: Drug: Oral azithromycin
PlaceboPlacebo comparatorOral Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced the Occurrence of a Third Episode of Post-RSV Wheezing (Recurrent Wheeze)

    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.

    Measured: Follow up duration of 18-48 months

Secondary outcomes (6)

  1. Number of Participants Who Had Physician Asthma Diagnosis

    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?".

    Measured: Follow up duration of 18-48 months

  2. Annualized Number of Days With Respiratory Symptoms (Wheezing, Cough, or Shortness of Breath)

    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.

    Measured: Follow up duration of 18-48 months

  3. Annualized Number of Days With Albuterol Use

    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.

    Measured: Follow up duration of 18-48 months

  4. Annualized Number of Oral Corticosteroid Courses

    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.

    Measured: Follow up duration of 18-48 months

  5. Annualized Number of Antibiotic Courses

    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.

    Measured: Follow up duration of 18-48 months

  6. Number of Participants Who Experienced Serious Adverse Events

    Serious Adverse Event were captured during clinic visits and by telephone interviews every other month using designed SAE form.

    Measured: Follow up duration of 18-48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionApr 2021
  4. Study completionApr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02911935
Sponsor's protocol ID
201603018
Acronym
APW-RSV-II
Status last verified
Jun 2022
First submitted
18 Sep 2016
Last updated
7 Jun 2022
Data monitoring committee
Yes
Individual data sharing
Yes: 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

Publications

  • Beigelman A, Goss CW, Wang J, Srinivasan M, Boomer J, Zhou Y, Bram S, Casper TJ, Coverstone AM, Kanchongkittiphon W, Kuklinski C, Storch GA, Schechtman KB, Castro M, Bacharier LB. Azithromycin therapy in infants hospitalized for respiratory syncytial virus bronchiolitis: Airway matrix metalloproteinase-9 levels and subsequent recurrent wheeze. Ann Allergy Asthma Immunol. 2024 May;132(5):623-629. doi: 10.1016/j.anai.2024.01.001. Epub 2024 Jan 17.

    PubMed 38237675

  • Beigelman A, Srinivasan M, Goss CW, Wang J, Zhou Y, True K, Ahrens E, Burgdorf D, Haslam MD, Boomer J, Bram S, Burnham CD, Casper TJ, Coverstone AM, Kanchongkittiphon W, Kuklinski C, Storch GA, Wallace MA, Yin-DeClue H, Castro M, Schechtman KB, Bacharier LB. Azithromycin to Prevent Recurrent Wheeze Following Severe Respiratory Syncytial Virus Bronchiolitis. NEJM Evid. 2022 Apr;1(4):10.1056/evidoa2100069. doi: 10.1056/evidoa2100069. Epub 2022 Feb 27.

    PubMed 37621674

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oral azithromycin in people with Respiratory Syncytial Virus, Bronchiolitis, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02911935, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.

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