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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avraham Beigelman, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01486758
First received: November 28, 2011
Last updated: May 15, 2017
Last verified: May 2017
  Purpose

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.

HYPOTHESES

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 Intervention Phase
RSV Bronchiolitis Drug: Azithromycin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.

  • 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:
  • Concentrations of IL-8 in Nasal Lavage on Day 15 [ Time Frame: Day 15 ]
  • Rates of Drug Related GI Side Effects. [ Time Frame: One month from randomization ]
  • 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

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

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


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  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: NCT01486758

Locations
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
Investigators
Principal Investigator: Avraham Beigelman, MD, MSCI Washington University School of Medicine
  More Information

Responsible Party: Avraham Beigelman, Assistant Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01486758     History of Changes
Other Study ID Numbers: 201107151
ICTS, Washington University ( Other Grant/Funding Number: CTSA402 )
Study First Received: November 28, 2011
Results First Received: April 12, 2016
Last Updated: May 15, 2017

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 August 21, 2017