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NCT03060473 · ClinicalTrials.gov registry record · Phase 3
Treatment of ppROM With Erythromycin vs. Azithromycin Trial
A Phase 3 study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT03060473: Clinical Trial Phase 3 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT03060473 is a Phase 3 study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060473, a Phase 3 study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This pregnancy complication is a major contributor to preterm births and results in neonatal morbidity and mortality. The current standard of care for PPROM subjects between the gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do not tolerate this regimen over the course of 7 days. In addition, there is a national shortage of erythromycin, and published expert opinion proposed to use a second-generation macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen.
Primary Outcome
Proportion of women still pregnant by day 7 after the diagnosis of PPROM is made. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen
Interventions
- DRUG Azithromycin
- DRUG Amoxicillin
- DRUG Erythromycin
- DRUG Ampicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-02-23 |
| Est. Completion | 2023-12-08 |
| Phase | Phase 3 |
Why NCT03060473 stopped before completion
NCT03060473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Azithromycin is the first listed.
NCT03060473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03060473 about?
NCT03060473 is a clinical study titled "Treatment of ppROM With Erythromycin vs. Azithromycin Trial". Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This pregnancy complication is a major contributor to preterm births and results in neonatal morbidity and mortality. The current standard of care for PPROM subjects between the gestational age of 24 weeks and 0 d...
What is the current status of trial NCT03060473?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2017-02-23. Estimated completion is 2023-12-08.
What interventions are being tested in trial NCT03060473?
The interventions under investigation include: Azithromycin (DRUG), Amoxicillin (DRUG), Erythromycin (DRUG), Ampicillin (DRUG).
Who is sponsoring clinical trial NCT03060473?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03060473's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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