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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00599053
Other study ID # F061228003
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received January 10, 2008
Last updated November 28, 2012
Start date May 2007
Est. completion date August 2009

Study information

Verified date August 2012
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
Azithromycin
10 mg/kg IV per dose given for 10 days

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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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