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

Study Overview
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Brief Summary
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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

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

Conditions
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Bacteria Infection, Respiratory Tract Infections

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Early treatment with azithromycin | Drug: Azithromycin<br>* 10 mg/kg IV per dose given for 10 days<br>|
| No Intervention: 2<br>Expectant (usual) management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | from day 1 of study drug through 100 days or discharge from hospital, which ever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from baseline to 100 days or discharge from Hospital, which ever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureaplasma, Bronchopulmonary dysplasia, very low birthweight