Status:
COMPLETED
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Endometritis
Eligibility:
FEMALE
19+ years
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 ...
Eligibility Criteria
Inclusion
- Women 19 years and older
- Term (37 weeks and greater)
- Singleton gestation
- Scheduled cesarean section
- Non-laboring
- Intact membranes
Exclusion
- \< 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01464840
Start Date
November 1 2011
End Date
August 1 2013
Last Update
May 11 2017
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249