NCT01982864

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2013

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

October 31, 2013

Last Update Submit

July 15, 2020

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

Aminoglycosideshemodialysisclinical pharmacokineticspharmacokinetic modellingBayesian estimationNecessityof the treatmentgentamicin

Outcome Measures

Primary Outcomes (1)

  • Concentration curves of gentamicin

    The research aims at performing a population pharmacokinetic (POPPK) study of gentamicin when given to hemodialysis patients. The ability to describe the concentration curves versus time (Biais (%) between the observed concentrations and the concentrations predicted by the model).

    1 week

Study Arms (1)

hemodialysis patients

EXPERIMENTAL

The administration of gentamicin at the beginning of the hemodialysis.

Drug: Gentamicin

Interventions

GentamicinDRUG

The decision to introduce the antibiotic is made during a session or between two sessions according to both the clinicians usual procedure. Depending on the number of injections, 8 to 10 blood samples will be drawn per patient. Clinical and biological data will be concomitantly collected (e.g., hemodialysis session duration, creatinine clearance…). The number of blood sampling and the time schedule will be adapted to the prescription and the possible follow-up of the treatment after the first injection. Whatever the time is between the first injection and the following dialysis session, a sampling will be performed 30 minutes after the end of the injection (T1), 8h after the end of the injection (T2), juste before (TAD), in the middle (TMD) and at the end of the dialysis (TFD).

hemodialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU LIMOGES - Laboratoire de Pharmacologie

Limoges, 87042, France

Location

CHU LIMOGES - Service Néphrologie

Limoges, 87042, France

Location

Related Publications (1)

  • Franck B, Monchaud C, Saint-Marcoux F, Rerolle JP, Allard J, Allot V, Marquet P, Essig M, Woillard JB. Population pharmacokinetics of gentamicin in haemodialysis patients: modelling, simulations and recommendations. Eur J Clin Pharmacol. 2020 Jul;76(7):947-955. doi: 10.1007/s00228-020-02867-3. Epub 2020 May 1.

    PMID: 32358683RESULT

MeSH Terms

Interventions

Gentamicins

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Pierre MARQUET, MD

    CHU LIMOGES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 13, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

FR(2)