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.
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 azithromycin prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin, 2) to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo, and 3) to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo. Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
8,000
500mg azithromycin in 250 mL of normal saline
250 mL of normal saline
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
University of Alabama - Birmingham
Birmingham, Alabama, United States
RECRUITINGRegents of the University of California San Francisco
San Francisco, California, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGUniversity of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGCase Western Reserve University
Cleveland, Ohio, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMagee Women's Hospital
Pittsburgh, Pennsylvania, United States
RECRUITING...and 4 more locations
Maternal infection composite
a maternal infection composite defined as any one of the following: endometritis, wound infection, abdominal or pelvic abscess, septic pelvic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection
Time frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)
Non-infections wound complications
any of the following wound complications without diagnosis of a wound infection: seroma, wound breakdown, erythema and/or hematoma
Time frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)
Perinatal composite outcome
Any of the following: * Neonatal death occurring within 28 days of birth or prior to initial discharge from hospital * Respiratory distress syndrome * Necrotizing enterocolitis grade 2 or higher * Periventricular leucomalacia * Intraventricular hemorrhage grades 3 or 4 * Bronchopulmonary dysplasia grade 3 or higher * Suspected sepsis * Confirmed sepsis * Cardiac resuscitation * Severe neonatal drug reaction defined as anaphylaxis or any other reported severe event suspected to be due to azithromycin * Hypertrophic pyloric stenosis defined as physician diagnosis supported by surgical intervention (pyloromyotomy) or pathology evaluation through 6 weeks from birth.
Time frame: hospital discharge, 6 weeks of birth, or death (whichever occurs first)
Number of neonates with Allergic Reaction
Neonatal allergic reaction (e.g., skin rash) through discharge or 7 days from birth, whichever is earliest, suspected to be due to study medication.
Time frame: birth through hospital discharge, or 7 days from birth, whichever is earliest
Number of Neonates with Gastrointestinal Symptoms
vomiting, diarrhea, feeding difficulty through discharge or 7 days from birth, whichever is earliest
Time frame: birth through hospital discharge, or 7 days from birth, whichever is earliest
Number of Maternal Deaths
Death
Time frame: From randomization through 6 weeks postpartum (a period of up to 6 weeks)
Maternal Resource Composite
* Hospital readmission * Emergency room (ER) visit * Unscheduled clinic visits
Time frame: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)
Neonatal Resource Composite
* Hospital readmission * Emergency Room (ER) visit
Time frame: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)
Maternal Hospital Length of Stay
Length of hospital stay in days
Time frame: Hospital admission to hospital discharge (up to 42 days)
Rate of Neonatal ICU Admission
Number of neonates admitted to NICU
Time frame: Delivery to hospital discharge (up to 120 days)
Number of Participants with Maternal Resistant Infection
bacteria and resistance patterns from clinical cultures
Time frame: Randomization through 6 weeks postpartum (a period of up to 6 weeks)
Number of Neonates with Neonatal Resistant Infection
bacteria and resistance patterns from clinical cultures
Time frame: From birth up to 6 weeks of age
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