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Effect of, OAT3, on the Renal Secretion of Cefotaxime

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187655
First Posted: September 16, 2005
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.

Condition Intervention Phase
Focus Groups Drug: Cefotaxime Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Genetic Variation in the Transporter, OAT3, on the Renal Secretion of Cefotaxime

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype [ Time Frame: post dose up to 24 hours ]
    Participants were stratified by their OCT3 genotype, heterozygous vs homozygous. The renal clearance of cefotaxime was measured by urine content of cefotaxime metabolites in participants after the single IV push administration of 2 grams of cefotaxime.


Enrollment: 24
Study Start Date: January 2004
Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cefotaxime
Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
Drug: Cefotaxime
Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
Other Names:
  • Claforan
  • Cefotaxime Sodium

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Previous participation in the "SOPHIE" study;
  2. Has a specific genotype for OAT3

Exclusion Criteria:

  1. Under 18 years old or over 45 years old;
  2. Pregnant (pregnancy status in female subjects will be determined by a urine pregnancy test before study drug administration);
  3. They report a prior history of any allergic reaction to cephalosporin antibiotic, or severe hypersensitivity to penicillin;
  4. Has a prior history of renal or hepatic dysfunction (renal and hepatic function will also be determined for each subject with prescreening blood tests);
  5. Taking a medication that could confound study results (such as known substrates or inhibitors of OATs);
  6. They do not consent to participate in the study.
  Contacts and Locations
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): NCT00187655


Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187655     History of Changes
Other Study ID Numbers: 867
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: May 21, 2013
Results First Posted: May 12, 2014
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by University of California, San Francisco:
Healthy volunteers willing to be dosed with cefotaxime

Additional relevant MeSH terms:
Cefotaxime
Cefoxitin
Anti-Bacterial Agents
Anti-Infective Agents