The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Endometritis Clinical Trial

— PKAZ  

Official title:

The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464840
• Other study ID #: F101111007
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: November 18, 2013
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometritis

Intervention

Drug:
• Azithromycin
500 mg intravenous infused over 1 hour

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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