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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

This study has been completed.
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 12, 2005
Last updated: October 25, 2016
Last verified: October 2016
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
Pregnancy 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:

Enrollment: 150
Study Start Date: April 2003
Study Completion Date: August 2010
Primary Completion Date: August 2010 (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   (Adult)
Sexes 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
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Please refer to this study by its identifier: NCT00214331

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53715
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: University of Wisconsin, Madison Identifier: NCT00214331     History of Changes
Other Study ID Numbers: 2002-524
FDA # 233-02-0114
Study First Received: September 12, 2005
Last Updated: October 25, 2016

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Protein Synthesis Inhibitors processed this record on September 19, 2017