Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Phase 1

Terminated

• Conditions: Respiratory Tract Infections; Bacteria Infection
• Interventions: Drug: Azithromycin

• Registration Number: NCT00599053
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Results First Submitted: 2012-05-30
• Results First Submitted QC: 2012-11-28
• Results First Posted: 2012-12-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Infants weighing <1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.

Exclusion Criteria

• Severe respiratory distress syndrome with survival unlikely >7 days, Congenital malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Azithromycin	Early treatment with azithromycin

Primary Outcome Measures

Name	Time	Method
Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants	100 days or discharge from hospital	Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy
Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants	100 days or discharge from hospital	Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.
Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants	from day 1 of study drug through 100 days or discharge from hospital, which ever comes first	Number of serious of adverse event experienced by subjects treated with azithromycin

Secondary Outcome Measures

Name	Time	Method
Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups	from baseline to 100 days or discharge from Hospital, which ever comes first	Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States