The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Completed

Conditions studied: Endometritis

In brief

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.

Key facts

Study ID

NCT01464840

Run by

University of Alabama at Birmingham

People needed

30

Starts

2011-11-01

Expected to finish

2013-08-01

Last updated by the study team

2017-05-11

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• < 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.