The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

University of Alabama at Birmingham30 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Endometritis

Interventions

AzithromycinDRUG

500 mg intravenous infused over 1 hour

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration

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.

Time frame: 48 hours after delivery

Data from ClinicalTrials.gov

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