CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 220 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00319956
NCT00319956Phase 2Completed
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Trial II of Lung Protection With Azithromycin in the Preterm Infant

Hubert Ballard·interventional·Posted Apr 27, 2006·Updated Jun 27, 2018

In Brief

A Phase 2 clinical trial evaluating Azithromycin and Placebo for Bronchopulmonary Dysplasia. Completed, enrolled 220 participants across 1 site.

Detailed Summary

The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD. The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia
CountriesUnited States
CollaboratorsAmerican Lung Association

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2006
Enrollment StartSep 1, 2004
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.2 years ago

Interventions

Azithromycindrug

Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.

Placebodrug

vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.