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Completed

NCT Number: NCT01464840

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.

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Key information

Conditions

Endometritis Adnexal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pelvic Inflammatory Disease Urogenital Diseases Uterine Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

500 mg intravenous infused over 1 hour

Other names: Zmax

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: PKAZ

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 4, 2011
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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