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Search / Trial NCT01982864

Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients.

Launched by UNIVERSITY HOSPITAL, LIMOGES · Nov 6, 2013

Trial Information

Current as of April 25, 2025

Terminated

Keywords

Aminoglycosides Hemodialysis Clinical Pharmacokinetics Pharmacokinetic Modelling Bayesian Estimation Necessity Of The Treatment Gentamicin

ClinConnect Summary

Recent evidence about the pharmacokinetics and pharmacodynamics of aminoglycosides strongly supports administration of aminoglycosides before, rather than after, hemodialysis. Therapeutic drug monitoring using pharmacokinetic modeling is currently used in non-hemodialysis patients. However, the PK tools employed are not suitable to dialysis patients.

For aminoglycosides, the ratio of peak to Minimal Inhibitory Concentration (MIC) has been shown to be the parameter that best correlates with clinical efficacy, whilst prolonged exposure to high concentrations have been related to either nephr...

Gender

ALL

Eligibility 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

Trial Officials

Pierre MARQUET, MD

Principal Investigator

CHU LIMOGES

About University Hospital, Limoges

The University Hospital of Limoges is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates patient care with cutting-edge research initiatives, fostering collaboration among healthcare professionals, researchers, and academic partners. With a commitment to improving patient outcomes and contributing to medical knowledge, the University Hospital of Limoges plays a pivotal role in translating scientific discoveries into effective therapeutic strategies. Its state-of-the-art facilities and expertise in various medical fields ensure rigorous trial management and adherence to ethical standards.

Locations

Limoges, , France

Limoges, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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