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Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Study acronym: PRACET
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Study completion pushed from Oct 1, 2026 to Oct 1, 2027
    • Eligibility criteria expanded, about 8 words
    • Publications: details revised at 3 of 3 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 1, 2026 to May 29, 2026
    • Site details revised at 2 of 2 sites
    v8
  3. Notable Primary completion date: Aug 1, 2025 to Aug 1, 2026
    • Study completion date: Oct 1, 2025 to Oct 1, 2026
    v7
  4. Notable Lead sponsor: Inova Fairfax Hospital to Inova Health Care Services
    • Site contacts updated at 1 of 2 sites
    v6
  5. Minor Site details revised at 1 of 2 sitesv5
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  1. Minor Study sites: 1 to 2
    • Collaborators expanded, about 4 words
    v4
  2. Minor Start date changed from estimate of Mar 2024 to Mar 8, 2024v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 1, 2024 to Mar 2024
    • Site details revised
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.
Trial Details
NCT Number NCT06273891
Lead Sponsor Inova Health Care Services
Collaborators: Eastern Virginia Medical School
Conditions
(from sponsor)
Premature Rupture of Membrane
Related terms [OBSOLETE] Preterm Premature Rupture of the Membranes, Premature Rupture of Fetal Membranes
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov