Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Conditions

• Cesarean Delivery
• Labor and Delivery Complication
• Obstetrical Complications

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• Azithromycin Injection — DRUG
  500mg azithromycin in 250 mL of normal saline
• Placebo — DRUG
  250 mL of normal saline
• Standard of Care Preoperative antibiotics — DRUG
  standard of care preoperative antibiotics (excluding azithromycin) prior to incision

Study Details

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.

Key Dates

Start date

Nov 6, 2024

Status verified

Apr 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

8,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Azithromycin prophylaxis and standard of care preoperative antibiotics
  500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
• Placebo Comparator: Placebo and standard of care preoperative antibiotics
  Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.

Primary Outcome Measure

Maternal infection composite [ Time Frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks) ]

Central Contacts

• Rebecca G Clifton, PhD
  301-881-9260
  [email protected]
• Steven Weiner, MS
  [email protected]

Locations (14)

Find similar trials in Birmingham, AL

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