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Sponsors and Collaborators: |
University of Wisconsin, Madison Food and Drug Administration (FDA) |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00214331 |
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.
Condition | Intervention | Phase |
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Pregnancy |
Drug: ciprofloxacin Drug: azithromycin Drug: gentamicin |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy |
Estimated Enrollment: | 150 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
ciprofloxacin
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Drug: ciprofloxacin
ciprofloxacin 500 mg twice a day for five doses.
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2
azithromycin
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Drug: azithromycin
azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
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3
gentamicin
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Drug: gentamicin
a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Pregnant women who are prescribed antibiotics as part of their clinical care
Inclusion Criteria:
Exclusion Criteria:
Contact: Gloria Sarto, MD, PhD | gsarto@wisc.edu |
United States, Illinois | |
University of Illinois at Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: James Fischer, PharmD 312-996-5549 jfischer@uic.edu | |
United States, Massachusetts | |
Harvard University | Recruiting |
Cambridge, Massachusetts, United States, 02115 | |
Contact: Kathryn Chen, MD 617-232-6346 kathychen@stanfordalumni.org | |
Boston University | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Karen Freund, MD 617-638-8878 karen.freund@bmc.org | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Tim Johnson, MD 734-764-8123 trbj@umich.edu | |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53715 | |
Contact: Gloria Sarto, MD, PhD gsarto@wisc.edu |
Study Chair: | Gloria Sarto, MD, PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Gloria Sarto, MD, PhD ) |
Study ID Numbers: | 2002-524, FDA # 233-02-0114 |
Study First Received: | September 12, 2005 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00214331 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ciprofloxacin Anti-Bacterial Agents Azithromycin Gentamicins |
Protein Synthesis Inhibitors Anti-Infective Agents Ciprofloxacin Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Azithromycin Gentamicins Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |