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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03060473
The ClinicalTrials.gov registry entry for NCT03060473 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Azithromycin is the first listed.
NCT03060473 reports 0 study locations.
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.
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