Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Completed

• Conditions: Pregnancy
• Interventions: Drug: azithromycin; Drug: gentamicin; Drug: ciprofloxacin

• Registration Number: NCT00214331
• Lead Sponsor: University of Wisconsin, Madison

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 documented infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	azithromycin	azithromycin
3	gentamicin	gentamicin
1	ciprofloxacin	ciprofloxacin

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States