The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

This study is currently recruiting participants.

Verified March 2013 by University of Alabama at Birmingham

Sponsor:

Information provided by (Responsible Party):

Amelia Sutton, MD, PhD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT01464840

First received: October 26, 2011

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 26, 2011
Last Updated Date	March 11, 2013
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 1, 2011)	Number of patients in each group that attain an adequate azithromycin concentration [ Time Frame: 48 hours after delivery ] [ Designated as safety issue: No ] 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 Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01464840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Maternal blood, maternal adipose tissue, maternal myometrium, maternal breast milk, amniotic fluid, and fetal cord blood.
Sampling Method	Probability Sample
Study Population	Pregnant women 19 years and older undergoing scheduled cesearean sections
Condition ^ICMJE	Endometritis
Intervention ^ICMJE	Drug: Azithromycin 500 mg intravenous infused over 1 hour Other Name: Zmax
Study Group/Cohort (s)	15 minutes 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. Intervention: Drug: Azithromycin 30 minutes 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. Intervention: Drug: Azithromycin 60 minutes 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. Intervention: Drug: Azithromycin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	April 2013
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	19 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01464840
Other Study ID Numbers ^ICMJE	F101111007
Has Data Monitoring Committee	No
Responsible Party	Amelia Sutton, MD, PhD, University of Alabama at Birmingham
Study Sponsor ^ICMJE	University of Alabama at Birmingham
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Alabama at Birmingham
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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