CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 121 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 20 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/NCT01778634
NCT01778634Phase 2Completed
CompareCT.gov

A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

University of Maryland, Baltimore·interventional·Posted Jan 29, 2013·Updated Nov 30, 2020

In Brief

A Phase 2 clinical trial evaluating Azithromycin and Placebo for Ureaplasma Infections. Completed, enrolled 121 participants across 7 sites.

Detailed Summary

The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUreaplasma Infections
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Mercy Medical Center, Johns Hopkins University, University of Virginia, University of Alabama at Birmingham, Christiana Care Health Services

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2013
Enrollment StartJul 1, 2013
Primary CompletionDec 1, 2016
Study CompletionNov 3, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.4 years ago

Interventions

Azithromycindrug

Azithromycin intravenous 20 mg/kg every 24 h x 3 days

Placebodrug

D5W