CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Tobramycindrug
Likely dose
Tobramycin 5 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03904836
NCT03904836Phase 1Completed

Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session

Maisonneuve-Rosemont Hospital·interventional·Posted Apr 5, 2019·Updated Feb 26, 2021

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 5, 2019
Enrollment StartJan 31, 2019
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.2 years ago

Interventions

Tobramycindrug

5 milligrams per kilogram intravenous for one dose