Recruiting

Vancomycin

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT04758442

Conditions

Vancomycin

Hematologic Malignancies

Febrile Neutropenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Additional blood sample

Study Details

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.

Conditions

Vancomycin

Hematologic Malignancies

Febrile Neutropenia

Study ID

NCT04758442

Start date

Feb 1, 2021

Status verified date

Feb, 2021

Completion date

Oct 31, 2021

Anticipated

Primary completion date

Oct 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vancomycin

Subjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection.

Interventions

Additional blood sample

Included subjects will provided three blood samples to follow vancomycin concentration

Primary outcome measure

  • Pharmacokinetic Parameters : Volume of Distribution [ Time Frame: During intravenous vancomycin treatment assessed to 72 hours ]
  • Pharmacokinetic Parameters : Vancomycin clearance [ Time Frame: During intravenous vancomycin treatment assessed to 72 hours ]

Central Contacts and Locations

Central contacts

Annie Brisebois-Boyer, Pharm.D, M. Sc

514-252-3400abriseboisboyer.hmr@ssss.gouv.qc.ca

TEAM HEMATO-VANCO, Pharm. D

514-252-3400residents.phm2021.cemtl@ssss.gouv.qc.ca

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montréal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Feb 17, 2021

Last verified

Feb, 2021

Keywords

  • Bayesian model
  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2021-02-17.