Endometritis Clinical Trial
— PKAZOfficial title:
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 48 hours after delivery | No |
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