Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: ciprofloxacin (Drug); azithromycin (Drug); gentamicin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
Gloria Sarto, MD, PhD, Study Chair, Affiliation: University of Wisconsin, Madison
Overall contact:
Gloria Sarto, MD, PhD, Email: gsarto@wisc.edu
Summary
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.
Clinical Details
Official title: Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Study design: Cohort, Prospective
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Gloria Sarto, MD, PhD, Email: gsarto@wisc.edu
University of Illinois at Chicago, Chicago, Illinois 60612, United States; Recruiting
James Fischer, PharmD, Phone: 312-996-5549, Email: jfischer@uic.edu
Harvard University, Cambridge, Massachusetts 02115, United States; Recruiting
Kathryn Chen, MD, Phone: 617-232-6346, Email: kathychen@stanfordalumni.org
Boston University, Boston, Massachusetts 02118, United States; Recruiting
Karen Freund, MD, Phone: 617-638-8878, Email: karen.freund@bmc.org
University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Tim Johnson, MD, Phone: 734-764-8123, Email: trbj@umich.edu
University of Wisconsin, Madison, Wisconsin 53715, United States; Recruiting
Gloria Sarto, MD, PhD, Email: gsarto@wisc.edu
Additional Information
UW Women's Heath Center of Excellence
Starting date: April 2003
Ending date: April 2011
Last updated: October 29, 2008
|
