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 Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: ciprofloxacin; Drug: azithromycin; Drug: gentamicin

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who are prescribed antibiotics as part of their clinical care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Study Chair: Gloria Sarto, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Gentamicins; Ciprofloxacin; Azithromycin
• Other Study ID Numbers: 2002-524; FDA # 233-02-0114