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NCT00599053 · ClinicalTrials.gov registry record · Phase 1
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00599053 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 7 participants.
The verdict
NCT00599053, a Phase 1 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study 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
Interventions
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00599053
The ClinicalTrials.gov registry entry for NCT00599053 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Azithromycin is the first listed.
NCT00599053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00599053 about?
NCT00599053 is a clinical study titled "Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates". 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 t...
What is the current status of trial NCT00599053?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2007-05. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00599053?
The interventions under investigation include: Azithromycin (DRUG).
Who is sponsoring clinical trial NCT00599053?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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