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Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology (Hemato-Vanco)

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ClinicalTrials.gov Identifier: NCT04758442
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Ciusss de L'Est de l'Île de Montréal

Study Description
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Brief Summary:
This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.

Condition or disease Intervention/treatment Phase
Vancomycin Hematologic Malignancies Febrile Neutropenia Other: Additional blood sample Not Applicable

Detailed Description:

STUDY DESIGN:

Prospective, monocentric, pharmacokinetic study.

Adults who have been diagnosed with a hematologic malignancy, are hospitalized at Maisonneuve-Rosemont hospital and received at least 3 doses of intravenous vancomycin.

Pharmacokinetic parameters: Serum vancomycin concentration measured at steady state just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and between 3 to 5 hours after the end of the infusion (additional blood draw during the elimination phase).

RECRUITMENT PROCESS:

A systematic daily screening of hospitalized patients diagnosed with a hematologic cancer will be made by the research team and the pharmacists 7 days a week. An information sheet will be given to all potential eligible patients at their admission. When intravenous vancomycin is prescribed, a member of the research team will explain the study and present the Information and Consent Form (ICF) to the potential participant to obtain his/her official informed consent.

DATA COLLECTION:

Three blood draws will be planned around the fourth or fifth dose of vancomycin and collected by the nursing team. The sampling scheme is as follows: just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and 3, 4 or 5 hours after the end of the infusion (additional blood draw during the elimination phase) according to the assigned time of the participant. The assigned time of the additional blood draw will be randomized at the inclusion of the subject in the study. A member of the research team will provide the tubes to the nurse, will write and save sampling times and will ship the blood samples to the laboratory.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology: a Nomogram Based on a Bayesian Population Model to Predict Initial Dosage of Vancomycin
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vancomycin
Subjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection.
 Other: Additional blood sample
Included subjects will provided three blood samples to follow vancomycin concentration


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic Parameters : Volume of Distribution [ Time Frame: During intravenous vancomycin treatment assessed to 72 hours ]
    Estimated from vancomycin serum concentrations and patient characteristics

  2. Pharmacokinetic Parameters : Vancomycin clearance [ Time Frame: During intravenous vancomycin treatment assessed to 72 hours ]
    Estimated from vancomycin serum concentrations and patient characteristics


Secondary Outcome Measures :
  1. Area Under the concentration-time Curve (AUC) [ Time Frame: between 0 to 24 hours during vancomycin administration ]
  2. Serum Vancomycin Through Concentration [ Time Frame: 5 minutes before the selected infusion ]
    Vancomycin concentration measured just before the next infusion

  3. Serum Vancomycin Peak Concentration [ Time Frame: 60 minutes after the end of the infusion ]
    Vancomycin concentration measured 1 hour after the end of vancomycin infusion

  4. Serum Vancomycin Elimination Phase Concentration [ Time Frame: 3 to 5 hours after the end of the infusion (+/- 30 minutes) ]
    Vancomycin concentration measured 3 to 5 hours after the end of vancomycin infusion


Eligibility Criteria
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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 diagnosed with a hematologic cancer;
  • Subjects hospitalized at Maisonneuve-Rosemont hospital between February 2021 and August 2021;
  • Intravenous vancomycin treatment prescribed by a doctor;
  • Subjects received at least 3 doses of intravenous vancomycin.

Exclusion Criteria:

  • Non-malignant diagnosis (aplastic anemia and rare metabolic diseases);
  • Subjects admitted to a critical care unit;
  • End-stage renal disease (GFR < 15 mL/min/1.73m2);
  • Patients undergoing dialysis/renal replacement therapy;

  • Acute kidney injury at the moment of the first vancomycin dosage (definition adapted from KDIGO criteria):

    1. Increase in serum creatinine by ≥ 26.5 umol/L within 48 hours or
    2. Increase in serum creatinine to ≥ 1.5 times baseline within prior 7 days
  • Pregnant women;
  • Severely burn patients;
  • Inability to give free and informed consent.
Contacts and Locations
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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): NCT04758442


Contacts
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Contact: Annie Brisebois-Boyer, Pharm.D, M. Sc 514-252-3400 ext 1553 abriseboisboyer.hmr@ssss.gouv.qc.ca
Contact: TEAM HEMATO-VANCO, Pharm. D 514-252-3400 ext 6124 residents.phm2021.cemtl@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
More Information
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Publications:
Pfizer Canada Inc. PRODUCT MONOGRAPH : VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP. Kirkland, QC Pfizer Canada Inc.;2018.

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Responsible Party: Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT04758442    
Other Study ID Numbers: 2021-2482
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 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 Ciusss de L'Est de l'Île de Montréal:
Bayesian model
Pharmacokinetics
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neutropenia
Febrile Neutropenia
Neoplasms
Neoplasms by Site
 Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders