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

Primary Purpose

RSV Bronchiolitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RSV Bronchiolitis

Eligibility Criteria

1 Month - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Azithromycin

Placebo

Arm Description

Oral azithromycin

Oral Placebo

Outcomes

Primary Outcome Measures

IL-8 Concentrations
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
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
Rates of Drug Related GI Side Effects.
Likelihood to Develop 3 or More Wheezing Episodes
Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
Respiratory Symptoms Following RSV Bronchiolitis
Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
Number of Children Who Were Prescribed Inhaled Corticosteroids
Proportion of Participants With a Physician Diagnosis of Asthma
The proportion of participants with a physician diagnosis of asthma

Full Information

First Posted
November 28, 2011
Last Updated
May 15, 2017
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01486758
Brief Title
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
Acronym
APW-RSV
Official Title
Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. HYPOTHESES In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in: Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Description
Oral azithromycin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
IL-8 Concentrations
Description
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.
Time Frame
Day 8
Title
Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes
Description
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.
Time Frame
3-52 weeks following randomization
Secondary Outcome Measure Information:
Title
Concentrations of IL-8 in Nasal Lavage on Day 15
Time Frame
Day 15
Title
Rates of Drug Related GI Side Effects.
Time Frame
One month from randomization
Title
Likelihood to Develop 3 or More Wheezing Episodes
Description
Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
Time Frame
Week 3-52
Title
Respiratory Symptoms Following RSV Bronchiolitis
Description
Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
Time Frame
3-52 weeks following randomization
Title
Number of Children Who Were Prescribed Inhaled Corticosteroids
Time Frame
3-52 weeks following randomization
Title
Proportion of Participants With a Physician Diagnosis of Asthma
Description
The proportion of participants with a physician diagnosis of asthma
Time Frame
Week 3-52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 1-18 months. 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). 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. Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor). 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 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 treatment with albuterol. Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast. Treatment with any antibiotics in the past 2 weeks. Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks. Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements). Participation in another clinical trial. Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion. Contraindication of use of azithromycin or any other macrolide antibiotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avraham Beigelman, MD, MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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