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

Primary Purpose

Bacteria Infection, Respiratory Tract Infections

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteria Infection focused on measuring Ureaplasma, Bronchopulmonary dysplasia, very low birthweight

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Early treatment with azithromycin

Expectant (usual) management

Outcomes

Primary Outcome Measures

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 discharge in subjects receiving therapy
Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Pharmacokinetic measures (AUC12) of subjects receiving azithromycin 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
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
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.

Full Information

First Posted
January 10, 2008
Last Updated
April 17, 2017
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00599053
Brief Title
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Official Title
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was terminated early due to a change in practice on the obstetrical side that included administering azithromycin to women with preterm labor.
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 Bronchopulmonary Dysplasia (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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteria Infection, Respiratory Tract Infections
Keywords
Ureaplasma, Bronchopulmonary dysplasia, very low birthweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Early treatment with azithromycin
Arm Title
2
Arm Type
No Intervention
Arm Description
Expectant (usual) management
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
10 mg/kg IV per dose given for 10 days
Primary Outcome Measure Information:
Title
Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Description
Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy
Time Frame
100 days or discharge from hospital
Title
Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Description
Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.
Time Frame
100 days or discharge from hospital
Title
Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
Description
Number of serious of adverse event experienced by subjects treated with azithromycin
Time Frame
from day 1 of study drug through 100 days or discharge from hospital, which ever comes first
Secondary Outcome Measure Information:
Title
Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups
Description
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.
Time Frame
from baseline to 100 days or discharge from Hospital, which ever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Schelonka, MD
Organizational Affiliation
University of Alabama at Birminham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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

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