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The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease

NCT02544984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-06

Study results available
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Summary

The purpose of this study is to determine if the prophylactic use of azithromycin will reduce the total number of days when unscheduled treatment is given outside of the home in a clinic, urgent care, emergency room or hospital setting between the respiratory illness season months (October 1-March 31) and subsequent 2 month follow-up (April and May)

Conditions

Interventions

DRUG

Azithromycin

Patients will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

DRUG

placebo

Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Ricardo A Mosquera, MD · University of Texas Medical School in Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544984 on ClinicalTrials.gov