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. )

First Received on January 10, 2008. Last Updated on August 13, 2010 History of Changes

Sponsor:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00599053

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 I Phase II

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:

Drug Information available for: Azithromycin

U.S. FDA Resources

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

Primary Outcome Measures:

Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants [ Time Frame: 100 days or discharge from hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection. [ Time Frame: 100 days or discharge from Hospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2010 (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 L. Schelonka, MD-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
Last Updated:	August 13, 2010
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 February 12, 2012