NCT00599053

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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

Conditions

• Bacteria Infection
• Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Azithromycin	10 mg/kg IV per dose given for 10 days

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-01-23
• Last updated: 2017-05-17
• Results posted: 2012-12-31

Locations

1 site across 1 country: United States