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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

NCT00214331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DRUG

ciprofloxacin

ciprofloxacin 500 mg twice a day for five doses.

DRUG

azithromycin

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

DRUG

gentamicin

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

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Gloria Sarto, MD, PhD · University of Wisconsin, Madison

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00214331 on ClinicalTrials.gov