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

NCT ID: NCT01486758

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-05-31

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:

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.

Conditions

RSV Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Azithromycin

Oral azithromycin

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.

Placebo

Oral Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Azithromycin

Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Avraham Beigelman

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avraham Beigelman, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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

St Louis, Missouri, United States

Countries

United States

Other Identifiers

ICTS, Washington University

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

201107151

Identifier Type: -

Identifier Source: org_study_id