CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Cefotaximedrug
Likely dose
Cefotaxime 2 grams intravenous push over 5 minutes as a single doseAI-extracted
Key inclusion· 2
  • ✓Previous participation in the SOPHIE study
  • ✓Has a specific genotype for OAT3
Key exclusion· 5
  • ✕Age under 18 or over 45 years
  • ✕Pregnant or positive pregnancy test
  • ✕Prior allergic reaction to cephalosporin antibiotics or severe hypersensitivity to penicillin
  • ✕Prior history of renal or hepatic dysfunction

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00187655
NCT00187655Phase 1Completed
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Effect of Genetic Variation in the Transporter, OAT3, on the Renal Secretion of Cefotaxime

University of California, San Francisco·interventional·Posted Sep 16, 2005·Updated Oct 29, 2014

In Brief

A Phase 1 clinical trial evaluating Cefotaxime for Focus Groups. Completed, enrolled 24 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocus Groups
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJan 1, 2004
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 20.8 years ago

Interventions

Cefotaximedrug

Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.