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

NCT01486758 | Completed Phase 2 Results DMC

• 2 other identifiers: 201107151ICTS, Washington University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

RSV Bronchiolitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 8

• 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.

  3-52 weeks following randomization

Secondary Outcomes (6)

• Concentrations of IL-8 in Nasal Lavage on Day 15

  Day 15

• Rates of Drug Related GI Side Effects.

  One month from randomization

• Likelihood to Develop 3 or More Wheezing Episodes

  Week 3-52

• Respiratory Symptoms Following RSV Bronchiolitis

  3-52 weeks following randomization

• Number of Children Who Were Prescribed Inhaled Corticosteroids

  3-52 weeks following randomization

Study Arms (2)

Azithromycin

ACTIVE COMPARATOR

Oral azithromycin

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Oral Placebo

Drug: Placebo

Interventions

Azithromycin DRUG

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

Azithromycin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

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

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Avraham Beigelman (PI)
• Organization: Washington University in St. Louis

beigelman_a@kids.wustl.edu

314-454-2694

Study Officials

• Avraham Beigelman, MD, MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 6, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)