Official Title: “Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy”

This protocol is a prospective, open-label, multicenter, population pharmacokinetic and pharmacodynamic study of selected anti-infective agents in pregnant women being treated for suspected or documented infections.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: April 2011

Intervention(s) in this Clinical Trial

• Drug: ciprofloxacin
  • ciprofloxacin 500 mg twice a day for five doses.
• Drug: azithromycin
  • azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
• Drug: gentamicin
  • a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • ciprofloxacin
• : 2
  • azithromycin
• : 3
  • gentamicin

Inclusion Criteria:

• Women in their second or third trimester of pregnancy
• Women currently receiving treatment or whose physician has made the decision to start treatment with ciprofloxacin, azithromycin or gentamicin for a suspected or documented infection
• Of childbearing potential and who either have never been pregnant or whose most recent pregnancy ended 3 months previously (control group)
• Women greater than 3 months postpartum and currently breast-feeding (substudy)

Exclusion Criteria:

• Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Wisconsin, Madison

Overall Clinical Trial Officials and Contacts

Gloria Sarto, MD, PhD Study Chair University of Wisconsin, Madison  

Overall Contact: Gloria Sarto, MD, PhD  gsarto@wisc.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00214331

Study ID Number: 2002-524

ClinicalTrials.gov Identifier: NCT00214331

Health Authority: United States: Institutional Review Board

UW Women's Heath Center of Excellence