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Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

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ClinicalTrials.gov Identifier: NCT00214331
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.

Condition or disease Intervention/treatment
Pregnancy Drug: ciprofloxacin Drug: azithromycin Drug: gentamicin

Study Design
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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy
Study Start Date : April 2003
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

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Groups and Cohorts
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Group/Cohort Intervention/treatment
1
ciprofloxacin
 Drug: ciprofloxacin
ciprofloxacin 500 mg twice a day for five doses.
2
azithromycin
 Drug: azithromycin
azithromycin 500 mg on day 1 followed by 250 mg on days 2-5
3
gentamicin
 Drug: gentamicin
a single intravenous dose of gentamicin 1.5mg/kg infused over 60 minutes


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who are prescribed antibiotics as part of their clinical care
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214331


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Food and Drug Administration (FDA)
Investigators
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Study Chair: Gloria Sarto, MD, PhD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214331    
Other Study ID Numbers: 2002-524
FDA # 233-02-0114
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Azithromycin
Ciprofloxacin
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Protein Synthesis Inhibitors