The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

April 4, 2017 updated by: Amelia Sutton, MD, PhD, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women 19 years and older undergoing scheduled cesearean sections

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Zmax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Amelia L Sutton, M.D., Ph.D., University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F101111007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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