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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Bacteria Infection; Respiratory Tract Infections

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00599053

F061228003

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

1

Experimental group

Description:

Early treatment with azithromycin

Treatment:

Drug: Azithromycin

2

No Intervention group

Description:

Expectant (usual) management