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Tobramycin Administered at the Beginning of Dialysis (ESRD)

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ClinicalTrials.gov Identifier: NCT03904836
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Lafrance, Maisonneuve-Rosemont Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Renal Dialysis Renal Failure, Chronic Drug: Tobramycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Tobramycin
Subjects with end-stage renal disease who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection
Drug: Tobramycin
5 milligrams per kilogram intravenous for one dose




Primary Outcome Measures :
  1. Ratio of maximum tobramycin concentration to minimal inhibitory concentration [ Time Frame: The timeframe for data collection for this outcome is 48 hours to 72 hours ]
    In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects in whom the maximum concentration is greater than or equal to 8 times that of the minimal inhibitory concentration


Secondary Outcome Measures :
  1. Tobramycin trough level [ Time Frame: The timeframe for data collection for this outcome is 48 hours to 72 hours ]
    In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects whose trough concentration of tobramycin is less than or equal to 2 mg / L.

  2. Residual clearance [ Time Frame: The timeframe for data collection for this outcome is 48 hours to 72 hours ]
  3. Clearance associated with hemodialysis [ Time Frame: The timeframe for data collection for this outcome is 48 hours to 72 hours ]
  4. Volume of distribution [ Time Frame: The timeframe for data collection for this outcome is 48 hours to 72 hours ]
  5. Total area under the curve [ Time Frame: The timeframe for data collection for this outcome is 0 to 48 or 72 hours (depending on time between the two dialysis) ]
  6. Area under the curve between 0 to 24h after administration [ Time Frame: The timeframe for data collection for this outcome is 0 to 24 hours ]
  7. Tobramycin concentration [ Time Frame: The timeframe for data collection for this outcome is 24 hours to 72 hours ]
    Tobramycin concentration 24h, 48h and 72h after administration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged 18 and over;
  • Subjects with end-stage renal disease who are on an intermittent hemodialysis program (three times a week, 3-4 hours) at the Hôpital Maisonneuve-Rosemont hemodialysis unit for at least one month;
  • Subjects with suspicion or diagnosis of Gram-negative rod-type bacteria infection for which an antibiotic is prescribed;
  • Subjects able to consent to the study (consent form read and signed by the subject).

Exclusion Criteria:

  • Contraindication or possible medical hazard related to the administration of tobramycin or to any ingredient in the formulation (e.g. sulphites), such as severe allergies or aminoglycoside-reported previous intolerances;
  • Variable residual renal function (e.g. acute or transient renal failure requiring occasional hemodialysis sessions, post-renal transplantation);
  • Conditions sensitive to the side effects of tobramycin (e.g. history of myasthenia gravis, Parkinson's disease, vestibular or auditory disorder);
  • Subjects with impaired volume of distribution (ie, severe burns [> 20%], significant ascites, decompensation for acute heart failure requiring hospitalization, admission to the critical care unit, cystic fibrosis, morbid obesity [dry weight greater than 50% of ideal weight]);
  • Pregnant or breastfeeding women;
  • Unstable hemodynamic status (risk of not tolerating / completing a 3-4 hour dialysis session);
  • Recent treatment with an aminoglycoside (<1 month);
  • Participation in another research protocol;
  • Inability to give free and informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904836


Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Jean-Philippe Lafrance, MD Maisonneuve-Rosemont Hospital
Publications:
Sandoz Canada Inc. Product monograph: Tobramycin injection USP. Boucherville, QC: Sandoz Canada Inc.; 2017.
ANSM. Bon usage des aminosides administrés par voie injectable: gentamicine, tobramycine, netilmicine, amikacine - Mise au point. Paris: National Security Agency of Medicines and Health Products; 2011.
Health Canada. Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry. Health Canada; 2018
Montreal east island integrated university health and social services center. Standard operating procedure: Tobramycin. Montreal: Maisonneuve-Rosemont Hospital; 2016.

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Responsible Party: Jean-Philippe Lafrance, Principal Investigator, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT03904836    
Other Study ID Numbers: 2019-1619
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Philippe Lafrance, Maisonneuve-Rosemont Hospital:
Chronic Renal Diseases
Kidney Failure, Chronic
Renal Failure, Chronic
Tobramycin
Aminoglycosides
Pharmacokinetics
Infection
Anti-Bacterial Agents
Antibiotics
Renal Insufficiency, Chronic
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents