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
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214331
First received: September 12, 2005
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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:

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
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

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00214331

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

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

No publications provided

Responsible Party: Gloria Sarto, MD, PhD, University of Wisconsin
ClinicalTrials.gov 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:
Ciprofloxacin
Gentamicins
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

ClinicalTrials.gov processed this record on October 23, 2014