Clinical Trial: The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

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 Summary:
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alabama at Birmingham

Dates:
Date Received: October 26, 2011
Date Started: November 2011
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2017