NCT06605118 Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
| NCT ID | NCT06605118 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The George Washington University Biostatistics Center |
| Condition | Obstetrical Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 8,000 participants in total. It began in 2024-11-06 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.
Eligibility Criteria
Inclusion Criteria: * ≥ 23 weeks' gestation (ACOG dating criteria) * Scheduled or prelabor cesarean delivery * Singleton or twin gestation Exclusion Criteria: * Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin * Chorioamnionitis * Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery * Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change) * Fetal demise or known major congenital anomaly * Azithromycin treatment within 7 days * Planned use of antimicrobial prophylaxis after delivery for any reason * Known structural heart disease or active cardiomyopathy (current ejection fraction\<40%) * Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin * Refusal or unable to obtain consent (e.g., language barrier) * Participating in another intervention study that influences the primary outcome in this study * Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
Contact & Investigator
Alan T.N. Tita, MD PhD
STUDY CHAIR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06605118 clinical trial?
This trial is open to female participants only, studying Obstetrical Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06605118 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 8,000 participants.
Is NCT06605118 currently recruiting?
Yes, NCT06605118 is actively recruiting participants. Contact the research team at rclifton@bsc.gwu.edu for enrollment information.
Where is the NCT06605118 trial being conducted?
This trial is being conducted at Birmingham, United States, San Francisco, United States, Chicago, United States, New York, United States and 10 additional locations.
Who is sponsoring the NCT06605118 clinical trial?
NCT06605118 is sponsored by The George Washington University Biostatistics Center. The principal investigator is Alan T.N. Tita, MD PhD at University of Alabama at Birmingham. The trial plans to enroll 8,000 participants.