Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | April 2003 |
| End Date: | April 2011 |
| Contact: | Gloria Sarto, MD, PhD |
| Email: | gsarto@wisc.edu |
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.
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
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