Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

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.

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