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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53715, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciprofloxacin

Drug

ciprofloxacin 500 mg twice a day for five doses.

Azithromycin

Drug

azithromycin 500 mg on day 1 followed by 250 mg on days 2-5

Gentamicin

Drug

a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

Food and Drug Administration (FDA)

Registry information

Important dates

Study start: 2003
Primary completion: 2010
Study completion: 2010
First posted: Sep 21, 2005
Registry last updated: Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed