Respiratory Tract Infections Clinical Trial
Official title:
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
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 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
Status | Terminated |
Enrollment | 7 |
Est. completion date | August 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 3 Days |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 dischargein subjects receiving therapy | 100 days or discharge from hospital | Yes |
Primary | Pharmacokinetics of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants | Pharmacokinetic measures (AUC12) of subjects receiving azithoromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first. | 100 days or discharge from hospital | Yes |
Primary | 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 | Yes |
Secondary | 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 | No |
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