NCT04294069

Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.

Conditions

• Preterm Premature Rupture of Membrane

Interventions

Type	Name	Description
DRUG	Azithromycin 500 mg	500mg azithromycin PO for seven days starting on admission
DRUG	Azithromycin Oral Product	1000mg azithromycin PO once at admission

Timeline

• Start date: 2020-09-14
• Primary completion: 2020-12-27
• Completion: 2021-04-01
• First posted: 2020-03-03
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study