Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Anti-Bacterial Agents; Azithromycin; Ciprofloxacin; Gentamicins

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