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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

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:

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.

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

NCT ID

NCT01486758

First Posted

November 28, 2011

Last Updated

May 15, 2017

Sponsor

Washington University School of Medicine

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

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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