Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

This study is currently recruiting participants.

Verified July 2010 by University of Wisconsin, Madison

First Received on September 12, 2005. Last Updated on July 15, 2010 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:	Observational Model: Cohort Time Perspective: 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:

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, 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:

Anti-Bacterial Agents
Gentamicins
Azithromycin
Ciprofloxacin
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012