Azithromycin and Ampicillin for Late PPROM

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

311

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

July 31, 2029

Conditions
Pregnancy Complications, InfectiousPremature BirthNeonatal Diseases and AbnormalitiesAntibiotic ProphylaxisLatency PeriodPrematurity
Interventions
DRUG

Intravenous Ampicillin followed by Oral Amoxicillin

This intervention consists of intravenous Ampicillin 2 grams every 6 hours for 48 hours, followed by oral Amoxicillin 500 mg every 8 hours for 5 days

DRUG

Ampicillin/Amoxicillin plus single-dose IV Azithromycin

This intervention includes intravenous Ampicillin 2 grams every 6 hours for 48 hours, followed by oral Amoxicillin 500 mg every 8 hours for 5 days, plus a single dose of intravenous Azithromycin 1 gram administered once at the start of treatment

All Listed Sponsors
lead

Sheba Medical Center

OTHER_GOV