The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

NCT01464840 | Completed Results

• 1 other identifier: F101111007
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometritis

Keywords

Pregnancy; Cesarean section; Antibiotic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

15 minutes

500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.

Drug: Azithromycin

30 minutes

500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.

Drug: Azithromycin

60 minutes

500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.

Drug: Azithromycin

Interventions

Azithromycin DRUG

500 mg intravenous infused over 1 hour

Also known as: Zmax

15 minutes; 30 minutes; 60 minutes

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women 19 years and older undergoing scheduled cesearean sections

You may qualify if:

• Women 19 years and older
• Term (37 weeks and greater)
• Singleton gestation
• Scheduled cesarean section
• Non-laboring
• Intact membranes

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood, maternal adipose tissue, maternal myometrium, maternal breast milk, amniotic fluid, and fetal cord blood.

MeSH Terms

Conditions

Endometritis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Amelia Sutton, M.D., Ph.D.
• Organization: University of Alabama at Birmingham

alsutton@uab.edu

205-934-5612

Study Officials

• Amelia L Sutton, M.D., Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow/Instructor, Maternal Fetal Medicine

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: November 4, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 11, 2017
• Results First Posted: January 9, 2014

Record last verified: 2017-04

Locations

US (1)