MedTrace Logo

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

NCT06605118 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Obstetrical Complications
  • Labor and Delivery Complication
  • Cesarean Delivery

Interventions

DRUG

Azithromycin Injection

500mg azithromycin in 250 mL of normal saline

DRUG

Placebo

250 mL of normal saline

DRUG

Standard of Care Preoperative antibiotics

standard of care preoperative antibiotics (excluding azithromycin) prior to incision

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Alabama at Birmingham

    collaborator OTHER

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Alan T.N. Tita, MD PhD · University of Alabama at Birmingham

  • Kim Boggess, MD · University of North Carolina, Chapel Hill

  • Monica Longo, MD PhD · Eunice Kennedy Shriver NICHD

  • Rebecca G Clifton, PhD · The George Washington University Biostatistics Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06605118 on ClinicalTrials.gov