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

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00599053
• Other study ID #: F061228003
• 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

Related Conditions & MeSH terms

• Bacteria Infection
• Birth Weight
• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Ureaplasma Infections

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