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Azithromycin and Ampicillin for Late PPROM

Study acronym: ALPRO
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Interventions: Ampicillin/Amoxicillin plus single-dose IV Azithromycin (Drug), Intravenous Ampicillin followed by Oral Amoxicillin (Drug) to Ampicillin/Amoxicillin plus single-dose PO Azithromycin (Drug), Intravenous Ampicillin followed by Oral Amoxicillin (Drug)
    • Study description revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07183462
Lead Sponsor Sheba Medical Center
Conditions
(from sponsor)		 Pregnancy Complications, Infectious, Premature Birth, Neonatal Diseases and Abnormalities, Antibiotic Prophylaxis, Latency Period, Prematurity
Related terms Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Pregnancy Complications, Infectious, Premature Birth
Enrollment 311 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov