MedTrace Logo

Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

NCT04294069 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-07-27

No results posted yet for this 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.

Conditions

  • Preterm Premature Rupture of Membrane

Interventions

DRUG

Azithromycin 500 mg

500mg azithromycin PO for seven days starting on admission

DRUG

Azithromycin Oral Product

1000mg azithromycin PO once at admission

Sponsors & Collaborators

  • Christiana Care Health Services

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Rupsa C Boelig, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2020-12-27
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294069 on ClinicalTrials.gov