Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Brief 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 documen...
Eligibility Criteria
Inclusion
- 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
- Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents
Key Trial Info
Start Date :
April 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00214331
Start Date
April 1 2003
End Date
August 1 2010
Last Update
October 27 2016
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53715