Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Food and Drug Administration (FDA)
Information provided by:
University of Wisconsin, Madison Identifier:
First received: September 12, 2005
Last updated: July 15, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Drug: ciprofloxacin
Drug: azithromycin
Drug: gentamicin
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 150
Study Start Date: April 2003
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who are prescribed antibiotics as part of their clinical care

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00214331

Contact: Gloria Sarto, MD, PhD

United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53715
Contact: Gloria Sarto, MD, PhD   
Sponsors and Collaborators
University of Wisconsin, Madison
Food and Drug Administration (FDA)
Study Chair: Gloria Sarto, MD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: Gloria Sarto, MD, PhD, University of Wisconsin Identifier: NCT00214331     History of Changes
Other Study ID Numbers: 2002-524  FDA # 233-02-0114 
Study First Received: September 12, 2005
Last Updated: July 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 02, 2016