Pregnancy
Conditions
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.
Interventions
DRUGciprofloxacin
ciprofloxacin 500 mg twice a day for five doses.
DRUGazithromycin
azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
DRUGgentamicin
a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
Sponsors
Food and Drug Administration (FDA)
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Countries
United States
Outcome results
None listed