The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

This study has been completed.
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: November 18, 2013
Last verified: November 2013

October 26, 2011
November 18, 2013
November 2011
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01464840 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Maternal blood, maternal adipose tissue, maternal myometrium, maternal breast milk, amniotic fluid, and fetal cord blood.

Probability Sample

Pregnant women 19 years and older undergoing scheduled cesearean sections

Endometritis
Drug: Azithromycin
500 mg intravenous infused over 1 hour
Other Name: Zmax
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2013
May 2013   (final data collection date for primary outcome measure)

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
Female
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464840
F101111007
No
Amelia Sutton, MD, PhD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Amelia L Sutton, M.D., Ph.D. University of Alabama at Birmingham
University of Alabama at Birmingham
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP