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The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464840
First Posted: November 4, 2011
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amelia Sutton, MD, PhD, University of Alabama at Birmingham
  Purpose

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.


Condition Intervention
Endometritis Drug: Azithromycin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Amelia Sutton, MD, PhD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Maternal blood, maternal adipose tissue, maternal myometrium, maternal breast milk, amniotic fluid, and fetal cord blood.

Enrollment: 30
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
15 minutes
500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Drug: Azithromycin
500 mg intravenous infused over 1 hour
Other Name: Zmax
30 minutes
500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Drug: Azithromycin
500 mg intravenous infused over 1 hour
Other Name: Zmax
60 minutes
500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Drug: Azithromycin
500 mg intravenous infused over 1 hour
Other Name: Zmax

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women 19 years and older undergoing scheduled cesearean sections
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464840


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Amelia L Sutton, M.D., Ph.D. University of Alabama at Birmingham
  More Information

Responsible Party: Amelia Sutton, MD, PhD, Fellow/Instructor, Maternal Fetal Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01464840     History of Changes
Other Study ID Numbers: F101111007
First Submitted: October 26, 2011
First Posted: November 4, 2011
Results First Submitted: November 2, 2013
Results First Posted: January 9, 2014
Last Update Posted: May 11, 2017
Last Verified: April 2017

Keywords provided by Amelia Sutton, MD, PhD, University of Alabama at Birmingham:
Pregnancy
Cesarean section
Antibiotic

Additional relevant MeSH terms:
Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases