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

Phase 2TerminatedNCT00599053

University of Alabama at Birmingham7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bacteria Infection Respiratory Tract Infections

Interventions

Outcomes

Primary Outcomes

Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants

Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy

Time frame: 100 days or discharge from hospital

Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants

Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.

Time frame: 100 days or discharge from hospital

Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants

Number of serious of adverse event experienced by subjects treated with azithromycin

Time frame: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first

Secondary Outcomes

Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups

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.

Time frame: from baseline to 100 days or discharge from Hospital, which ever comes first