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NCT01778634 · ClinicalTrials.gov registry record · Phase 2
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
NCT01778634: Completed Phase 2 study, sponsored by University of Maryland, Baltimore.
NCT01778634 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01778634, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.
Primary Outcome
Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).
Interventions
- DRUG Placebo
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2013-07 |
| Est. Completion | 2020-11-03 |
| Phase | Phase 2 |
What the finished NCT01778634 record still lists
NCT01778634 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01778634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01778634 about?
NCT01778634 is a clinical study titled "Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants". The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.
What is the current status of trial NCT01778634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2013-07. Estimated completion is 2020-11-03.
What interventions are being tested in trial NCT01778634?
The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT01778634?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01778634's enrollment target sits among peer trials
121 567th of 2000 higher than 1,432 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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