The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Completed

• Conditions: Endometritis
• Interventions: Drug: Azithromycin

• Registration Number: NCT01464840
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-26
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-04
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Results First Submitted: 2013-11-02
• Results First Submitted QC: 2013-11-18
• Results First Posted: 2014-01-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
60 minutes	Azithromycin	500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
30 minutes	Azithromycin	500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
15 minutes	Azithromycin	500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.

Primary Outcome Measures

Name	Time	Method
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration	48 hours after delivery	The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States