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

This study has been terminated.
(Enrollment was terminated early due to a change in practice on the obstetrical side that included administering azithromycin to women with preterm labor.)
Sponsor:
Information provided by (Responsible Party):
Robert Schelonka, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00599053
First received: January 10, 2008
Last updated: November 28, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Bacteria Infection
Respiratory Tract Infections
Drug: Azithromycin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants [ Time Frame: 100 days or discharge from hospital ] [ Designated as safety issue: Yes ]
    Number of subjects without ureaplasma spp at 100 days after study entry or at hospital dischargein subjects receiving therapy

  • Pharmacokinetics of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants [ Time Frame: 100 days or discharge from hospital ] [ Designated as safety issue: Yes ]
    Pharmacokinetic measures (AUC12) of subjects receiving azithoromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.

  • Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants [ Time Frame: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first ] [ Designated as safety issue: Yes ]
    Number of serious of adverse event experienced by subjects treated with azithromycin


Secondary Outcome Measures:
  • Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups [ Time Frame: from baseline to 100 days or discharge from Hospital, which ever comes first ] [ Designated as safety issue: No ]
    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.


Enrollment: 7
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early treatment with azithromycin
Drug: Azithromycin
10 mg/kg IV per dose given for 10 days
No Intervention: 2
Expectant (usual) management

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599053

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Robert L Schelonka, MD University of Alabama at Birminham
  More Information

No publications provided

Responsible Party: Robert Schelonka, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00599053     History of Changes
Other Study ID Numbers: F061228003
Study First Received: January 10, 2008
Results First Received: May 30, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Ureaplasma
Bronchopulmonary dysplasia
very low birthweight

Additional relevant MeSH terms:
Birth Weight
Respiratory Tract Infections
Ureaplasma Infections
Body Weight
Signs and Symptoms
Infection
Respiratory Tract Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014