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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: Clinical Trial Phase 1 study, sponsored by University of Alabama at Birmingham.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy
Interventions
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
Why NCT00599053 stopped before completion
NCT00599053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Azithromycin is the first listed.
NCT00599053 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00599053's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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