drugset / Trial / NCT04294069

Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

NCT04294069

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

EvaluationDrugModalityDoseRoute
Comparator Azithromycin Small molecule 500 mg Oral
Comparator Azithromycin Small molecule 1000 mg Oral