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

February 12, 2021 updated by: Ciusss de L'Est de l'Île de Montréal

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters : Volume of Distribution
Time Frame: During intravenous vancomycin treatment assessed to 72 hours
Estimated from vancomycin serum concentrations and patient characteristics
During intravenous vancomycin treatment assessed to 72 hours
Pharmacokinetic Parameters : Vancomycin clearance
Time Frame: During intravenous vancomycin treatment assessed to 72 hours
Estimated from vancomycin serum concentrations and patient characteristics
During intravenous vancomycin treatment assessed to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the concentration-time Curve (AUC)
Time Frame: between 0 to 24 hours during vancomycin administration
between 0 to 24 hours during vancomycin administration
Serum Vancomycin Through Concentration
Time Frame: 5 minutes before the selected infusion
Vancomycin concentration measured just before the next infusion
5 minutes before the selected infusion
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
60 minutes after the end of the infusion
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
3 to 5 hours after the end of the infusion (+/- 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

October 31, 2021

Study Completion (ANTICIPATED)

October 31, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (ACTUAL)

February 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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