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Effect of, OAT3, on the Renal Secretion of Cefotaxime

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ClinicalTrials.gov Identifier: NCT00187655
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : May 12, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Focus Groups Drug: Cefotaxime Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : January 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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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.

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

Publications of Results:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187655     History of Changes
Other Study ID Numbers: 867
First Posted: September 16, 2005    Key Record Dates
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