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Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

ConditionsObstetrical ComplicationsLabor and Delivery ComplicationCesarean Delivery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorThe George Washington University Biostatistics Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

≥ 23 weeks' gestation (ACOG dating criteria)

Scheduled or prelabor cesarean delivery

Singleton or twin gestation

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

8,000 Participants
are divided into 2 treatment groups
Group A: Azithromycin prophylaxis and standard of care preoperative antibioticsExperimental treatment 2 interventions
Group B: Placebo and standard of care preoperative antibioticsPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The George Washington University Biostatistics Center

Lead sponsor

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

Collaborator

University of Alabama at Birmingham

Collaborator

Source ClinicalTrials.gov
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