At a glance
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Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session
In Brief
A Phase 1 clinical trial evaluating Tobramycin for Renal Dialysis and Renal Failure, Chronic. Completed, enrolled 11 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate whether the administration of a full tobramycin dose (5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has been diagnosed with Gram-negative rod-type infection. It is anticipated that the administration of a single 5 mg/kg dose of tobramycin during the first 30 minutes of a hemodialysis session will achieve an optimal ratio of maximum tobramycin concentration to minimal inhibitory concentration (Cmax/CMI) of 8 to 10 while limiting the accumulation (trough \< 2 mg/L before the next hemodialysis session) in end-stage renal disease subjects requiring intermittent hemodialysis sessions.
Study Details
Timeline
Interventions
5 milligrams per kilogram intravenous for one dose