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Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis (APW-RSV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01486758
Recruitment Status : Completed
First Posted : December 6, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Avraham Beigelman, Washington University School of Medicine

Brief Summary:

This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis.


In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:

  1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
  2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.

Condition or disease Intervention/treatment Phase
RSV Bronchiolitis Drug: Azithromycin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
Study Start Date : December 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Azithromycin
Oral azithromycin
Drug: Azithromycin
Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.

Placebo Comparator: Placebo
Oral Placebo
Drug: Placebo

Primary Outcome Measures :
  1. IL-8 Concentrations [ Time Frame: Day 8 ]
    Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.

  2. Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes [ Time Frame: 3-52 weeks following randomization ]
    Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.

Secondary Outcome Measures :
  1. Concentrations of IL-8 in Nasal Lavage on Day 15 [ Time Frame: Day 15 ]
  2. Rates of Drug Related GI Side Effects. [ Time Frame: One month from randomization ]
  3. Likelihood to Develop 3 or More Wheezing Episodes [ Time Frame: Week 3-52 ]
    Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis

  4. Respiratory Symptoms Following RSV Bronchiolitis [ Time Frame: 3-52 weeks following randomization ]
    Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)

  5. Number of Children Who Were Prescribed Inhaled Corticosteroids [ Time Frame: 3-52 weeks following randomization ]
  6. Proportion of Participants With a Physician Diagnosis of Asthma [ Time Frame: Week 3-52 ]
    The proportion of participants with a physician diagnosis of asthma

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Age: 1-18 months.
  2. Hospitalization for the first episode of RSV bronchiolitis:

    • Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND
    • 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).
  3. Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.
  4. Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
  5. Willingness to provide informed consent by the child's parent or guardian


Exclusion Criteria:

  1. Prematurity (gestational age < 36 weeks).
  2. Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.
  3. Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
  4. The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
  5. History of previous (before the current episode) wheeze or previous treatment with albuterol.
  6. Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
  7. Treatment with any antibiotics in the past 2 weeks.
  8. Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
  9. Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
  10. Participation in another clinical trial.
  11. Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
  12. Contraindication of use of azithromycin or any other macrolide antibiotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01486758

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United States, Missouri
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Avraham Beigelman, MD, MSCI Washington University School of Medicine
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Responsible Party: Avraham Beigelman, Assistant Professor of Pediatrics, Washington University School of Medicine Identifier: NCT01486758    
Other Study ID Numbers: 201107151
ICTS, Washington University ( Other Grant/Funding Number: CTSA402 )
First Posted: December 6, 2011    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents