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

Stopped early · Phase 1/Phase 2

Conditions studied: Bacteria Infection, Respiratory Tract Infections

In brief

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

Key facts

Study ID

NCT00599053

Run by

University of Alabama at Birmingham

People needed

7

Starts

2007-05-01

Expected to finish

2009-08-01

Last updated by the study team

2017-05-17

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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