Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Completed

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT00214331

Run by

University of Wisconsin, Madison

People needed

150

Starts

2003-04-01

Expected to finish

2010-08-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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