drugset / Trial / NCT04294069
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-09-14
- Primary completion
- 2020-12-27
- Completion
- 2021-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 500 mg | Oral |
| Comparator | Azithromycin | Small molecule | 1000 mg | Oral |