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

NCT ID: NCT00599053

Last Updated: 2017-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Bacteria Infection Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Early treatment with azithromycin

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

10 mg/kg IV per dose given for 10 days

2

Expectant (usual) management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Azithromycin

10 mg/kg IV per dose given for 10 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Robert Schelonka

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert L Schelonka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birminham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F061228003

Identifier Type: -

Identifier Source: org_study_id

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