Azithromycin and Ampicillin for Late PPROM

Sponsor
Sheba Medical Center
Study ID
NCT07183462
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Antibiotic Prophylaxis
  • Latency Period
  • Neonatal Diseases and Abnormalities
  • Pregnancy Complications, Infectious
  • Premature Birth
  • Prematurity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravenous Ampicillin followed by Oral Amoxicillin — DRUG
    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
  • Ampicillin/Amoxicillin plus single-dose PO Azithromycin — DRUG
    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 oral Azithromycin 1 gram administered once at the start of treatment

Study Details

The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy. The main question it aims to answer is: Does the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone? Researchers will compare two antibiotic regimens: Ampicillin alone, which is the current standard care Ampicillin with azithromycin, a broader regimen that may better prevent infections and prolong pregnancy Participants will: Receive one of the two antibiotic treatments during hospitalization. Be monitored until delivery for signs of infection and labor All participants will stay in the hospital until delivery. The study also looks at how the antibiotic choice may affect the time between membrane rupture and delivery, maternal infections, and the need for neonatal intensive care.

Key Dates

First listed
Sep 19, 2025
Start date
Sep 10, 2025
Status verified
May 2025
Primary completion
Jun 30, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
311 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard antibiotic regimen (Ampicillin and Amoxicillin)
    Participants in the control arm receive the standard antibiotic regimen for late PPROM, consisting of intravenous Ampicillin 2g every 6 hours for 48 hours, followed by oral Amoxicillin 500mg every 8 hours for 5 days, administered according to current clinical guidelines
  • Experimental: Intervention Arm - Standard Antibiotics with Azithromycin
    Participants in this arm will receive the standard antibiotic regimen of intravenous Ampicillin followed by oral Amoxicillin, plus a single dose of 1 gram oral Azithromycin

Primary Outcome Measure

A composite of neonatal adverse outcomes [ Time Frame: From the time of birth until 72 hours postpartum ]

Central Contacts

Related Studies