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
  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 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 ] [ 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.


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

Ages Eligible for Study:   19 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 26, 2011
Results First Received: November 2, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Pregnancy
Cesarean section
Antibiotic

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

ClinicalTrials.gov processed this record on October 19, 2014