Clinical trial

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

Name

20G.119

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.

Trial arms

Trial start

2020-09-14

Estimated PCD

2020-12-27

Trial end

2021-04-01

Status

Completed

Phase

Early phase I

Treatment

Azithromycin 500 mg

500mg azithromycin PO for seven days starting on admission

Arms:

Azithromycin 500mg

Azithromycin Oral Product

1000mg azithromycin PO once at admission

Arms:

Azithromycin 1000mg

Size

Primary endpoint

Azithromycin trough in amniotic fluid

8 days

Eligibility criteria

Inclusion Criteria: * Singleton gestation 24 0/7 -33 0/7 weeks' * Diagnosed with preterm premature rupture of membranes: * History consistent with ruptured membranes (ie leaking, gush of fluid) * Sterile speculum exam with pooling * Fluid positive for ferning and/or nitrazine * With or without confirmatory test such as Amnisure Exclusion Criteria: * • Contraindication to azithromycin * Active labor, abruption, chorioamnionitis at enrollment * Other contraindication to expectant management of PPROM at enrollment

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

Updated at

2023-07-27

1 organization

1 product

1 indication

Organization

Thomas Jefferson University

Product

Azithromycin

Indication

Preterm Premature Rupture of Membrane