The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

The University of Alabama at Birmingham

Status: Completed

Conditions: Endometritis

Treatments: Drug: Azithromycin

Study type: Observational

Funder types: Other

Identifiers

NCT01464840

F101111007

Details and patient eligibility

About

PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.

Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.

Enrollment: 30 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women 19 years and older
• Term (37 weeks and greater)
• Singleton gestation
• Scheduled cesarean section
• Non-laboring
• Intact membranes

Exclusion criteria

• < 19 years of age
• Preterm (< 37 weeks)
• Multifetal gestation
• Laboring or ruptured membranes
• Known fetal anomaly
• Oligo- or polyhydramnios
• Macrolide allergy
• Macrolide exposure within 2 weeks
• Medical co-morbidities
• Hepatic or renal impairment
• Taking medications that prolong the QT interval
• Currently taking nelfinavir, efavirenz, or flucanozole
• Structural heart defects or arrythmia

Trial design

30 participants in 3 patient groups

15 minutes

Description:

500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.

Treatment:

Drug: Azithromycin

30 minutes

Description:

500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.

Treatment:

Drug: Azithromycin

60 minutes

Description:

500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.

Treatment:

Drug: Azithromycin