Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology

NCT04758442 | Unknown

• 1 other identifier: 2021-2482
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Bayesian model; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic Parameters : Volume of Distribution

  Estimated from vancomycin serum concentrations and patient characteristics

  During intravenous vancomycin treatment assessed to 72 hours

• Pharmacokinetic Parameters : Vancomycin clearance

  Estimated from vancomycin serum concentrations and patient characteristics

  During intravenous vancomycin treatment assessed to 72 hours

Secondary Outcomes (4)

• Area Under the concentration-time Curve (AUC)

  between 0 to 24 hours during vancomycin administration

• Serum Vancomycin Through Concentration

  5 minutes before the selected infusion

• Serum Vancomycin Peak Concentration

  60 minutes after the end of the infusion

• Serum Vancomycin Elimination Phase Concentration

  3 to 5 hours after the end of the infusion (+/- 30 minutes)

Study Arms (1)

Vancomycin

EXPERIMENTAL

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

Other: Additional blood sample

Interventions

Additional blood sample OTHER

Included subjects will provided three blood samples to follow vancomycin concentration

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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):
• Increase in serum creatinine by ≥ 26.5 umol/L within 48 hours or
• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Related Publications (17)

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• Pfizer Canada Inc. PRODUCT MONOGRAPH : VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP. Kirkland, QC Pfizer Canada Inc.;2018.

  BACKGROUND

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  PMID: 24165176 BACKGROUND

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MeSH Terms

Conditions

Hematologic Neoplasms; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Central Study Contacts

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

CONTACT

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

TEAM HEMATO-VANCO, Pharm. D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 17, 2021
• Study Start: February 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

CA (1)