Azithromycin for Children Hospitalized With Asthma

NCT02003911 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2020-08-13

Study results available
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Summary

Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Despite limited clinical evidence, some pediatricians use azithromycin in children hospitalized with asthma, citing either treatment of atypical pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.

Conditions

Interventions

DRUG

Azithromycin

Azithromycin suspension (200mg/5mL)

DRUG

Placebo

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Lindsey C Douglas, MD · Montefiore Medical Center

  • Katherine O'Connor, MD · Montefiore Medical Center

  • Diana S. Lee, MD · Montefiore Medical Center

  • Alyssa H Silver, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-06-01
Completion
2018-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT02003911 on ClinicalTrials.gov