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NCT04294069 · ClinicalTrials.gov registry record · Phase 4
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
A Phase 4 study of Preterm Premature Rupture of Membrane, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04294069: Completed Phase 4 study of Preterm Premature Rupture of Membrane, sponsored by Thomas Jefferson University.
NCT04294069 is a Phase 4 study of Preterm Premature Rupture of Membrane that has completed, run by Thomas Jefferson University. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294069, a Phase 4 study of Preterm Premature Rupture of Membrane, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.
Primary Outcome
Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test
Conditions Studied
Interventions
- DRUG Azithromycin 500 mg
- DRUG Azithromycin Oral Product
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 4 |
What the finished NCT04294069 record still lists
NCT04294069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Preterm Premature Rupture of Membrane appearing as the primary indexed condition, and to 2 interventions - of which Azithromycin 500 mg is the first listed.
NCT04294069 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04294069 about?
NCT04294069 is a clinical study titled "Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial". This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500m...
What is the current status of trial NCT04294069?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2020-09-14. Estimated completion is 2021-04-01.
What conditions does trial NCT04294069 study?
This clinical trial studies the following conditions: Preterm Premature Rupture of Membrane.
What interventions are being tested in trial NCT04294069?
The interventions under investigation include: Azithromycin 500 mg (DRUG), Azithromycin Oral Product (DRUG).
Who is sponsoring clinical trial NCT04294069?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04294069 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04294069's enrollment target sits among peer trials
6 1984th of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
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