Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

University of Wisconsin (UW)

Status

Completed

Conditions

Pregnancy

Treatments

Drug: ciprofloxacin

Drug: azithromycin

Drug: gentamicin

Study type

Observational

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00214331

FDA # 233-02-0114

2002-524

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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