Overview

Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients.

Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
Aminoglycosides are widely used for the treatment of Gram-negative bacilli and Staphylococcus aureus infections because of their effectiveness and low cost. Nevertheless, many aspects of their optimal use in hemodialysis patients remain unsolved and little is known about their pharmacokinetics in this context. The current practice for prescribing aminoglycosides to these particular patients consists in giving after each hemodialysis session about half the dose usually given to patients with normal renal function. However, theoretical considerations and emerging clinical data suggest that this may not be the most beneficial dosing regimen as efficient peak concentrations are often not attained and the occurrence of ototoxicity and nephrotoxicity is still frequent.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Limoges
Treatments:
Gentamicins
Criteria
Inclusion Criteria:

- age upper to 18 years

- Patients hospitalized in the "Service de Néphrologie - Hémodialyse, Transplantations,
CHU de Limoges"

- Patients requiring chronic hemodialysis

- Patients requiring a treatment by aminoglycosides

- Patients willing to give their written informed consent for their participation to the
study

- Patients affiliated to the French social security system or equivalent

Exclusion Criteria:

- Patients under legal protection

- Patients unable or unwilling to provide informed consent and not under legal
protection

- Patients deprived of liberty

- Contraindications to gentamicin

- Pregnant or breast-feeding women or women of childbearing potential without efficient
contraception (based on declaration)

- Patients with any altered mental status or any psychiatric condition that would
interfere with the understanding of the study

- Patients enrolled in another clinical trial testing drugs or therapeutic strategies