Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, October 2008

First Received: September 12, 2005 Last Updated: October 29, 2008 History of Changes

Sponsor:	University of Wisconsin, Madison
Collaborator:	Food and Drug Administration (FDA)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214331

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Azithromycin Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Gentamicins

U.S. FDA Resources

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

Biospecimen Retention: None Retained

Biospecimen Description:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214331

Contacts

Contact: Gloria Sarto, MD, PhD

gsarto@wisc.edu

Locations

United States, Illinois
University of Illinois at Chicago	Recruiting
Chicago, Illinois, United States, 60612
Contact: James Fischer, PharmD 312-996-5549 jfischer@uic.edu
United States, Massachusetts
Harvard University	Recruiting
Cambridge, Massachusetts, United States, 02115
Contact: Kathryn Chen, MD 617-232-6346 kathychen@stanfordalumni.org
Boston University	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Karen Freund, MD 617-638-8878 karen.freund@bmc.org
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tim Johnson, MD 734-764-8123 trbj@umich.edu
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

Additional Information:

UW Women's Heath Center of Excellence This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Wisconsin ( Gloria Sarto, MD, PhD )
Study ID Numbers:	2002-524, FDA # 233-02-0114
Study First Received:	September 12, 2005
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00214331 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Ciprofloxacin
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Azithromycin
Gentamicins
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010