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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
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: Observational Model: Cohort, Time Perspective: 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 Wisconsin, Madison, Wisconsin 53715, United States; Recruiting
Gloria Sarto, MD, PhD, Email: gsarto@wisc.edu
Additional Information

Starting date: April 2003
Last updated: July 15, 2010

Page last updated: August 23, 2015

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