Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology
NCT ID: NCT04758442
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-02-01
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Vancomycin
Subjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection.
Additional blood sample
Included subjects will provided three blood samples to follow vancomycin concentration
Interventions
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Additional blood sample
Included subjects will provided three blood samples to follow vancomycin concentration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Locations
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Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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References
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Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.
Wingard JR, Hsu J, Hiemenz JW. Hematopoietic stem cell transplantation: an overview of infection risks and epidemiology. Infect Dis Clin North Am. 2010 Jun;24(2):257-72. doi: 10.1016/j.idc.2010.01.010.
Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. doi: 10.2146/ajhp080434. No abstract available.
Pfizer Canada Inc. PRODUCT MONOGRAPH : VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP. Kirkland, QC Pfizer Canada Inc.;2018.
Rybak MJ. The pharmacokinetic and pharmacodynamic properties of vancomycin. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S35-9. doi: 10.1086/491712.
Zhao W, Zhang D, Fakhoury M, Fahd M, Duquesne F, Storme T, Baruchel A, Jacqz-Aigrain E. Population pharmacokinetics and dosing optimization of vancomycin in children with malignant hematological disease. Antimicrob Agents Chemother. 2014 Jun;58(6):3191-9. doi: 10.1128/AAC.02564-13. Epub 2014 Mar 24.
Okada A, Kariya M, Irie K, Okada Y, Hiramoto N, Hashimoto H, Kajioka R, Maruyama C, Kasai H, Hamori M, Nishimura A, Shibata N, Fukushima K, Sugioka N. Population Pharmacokinetics of Vancomycin in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Pharmacol. 2018 Sep;58(9):1140-1149. doi: 10.1002/jcph.1106. Epub 2018 May 15.
Aljutayli A, Marsot A, Nekka F. An Update on Population Pharmacokinetic Analyses of Vancomycin, Part I: In Adults. Clin Pharmacokinet. 2020 Jun;59(6):671-698. doi: 10.1007/s40262-020-00866-2.
Marsot A, Boulamery A, Bruguerolle B, Simon N. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet. 2012 Jan 1;51(1):1-13. doi: 10.2165/11596390-000000000-00000.
Neely MN, Youn G, Jones B, Jelliffe RW, Drusano GL, Rodvold KA, Lodise TP. Are vancomycin trough concentrations adequate for optimal dosing? Antimicrob Agents Chemother. 2014;58(1):309-16. doi: 10.1128/AAC.01653-13. Epub 2013 Oct 28.
Bury D, Ter Heine R, van de Garde EMW, Nijziel MR, Grouls RJ, Deenen MJ. The effect of neutropenia on the clinical pharmacokinetics of vancomycin in adults. Eur J Clin Pharmacol. 2019 Jul;75(7):921-928. doi: 10.1007/s00228-019-02657-6. Epub 2019 Mar 15.
Jarkowski A 3rd, Forrest A, Sweeney RP, Tan W, Segal BH, Almyroudis N, Wang ES, Wetzler M. Characterization of vancomycin pharmacokinetics in the adult acute myeloid leukemia population. J Oncol Pharm Pract. 2012 Mar;18(1):91-6. doi: 10.1177/1078155211402107. Epub 2011 Apr 26.
Buelga DS, del Mar Fernandez de Gatta M, Herrera EV, Dominguez-Gil A, Garcia MJ. Population pharmacokinetic analysis of vancomycin in patients with hematological malignancies. Antimicrob Agents Chemother. 2005 Dec;49(12):4934-41. doi: 10.1128/AAC.49.12.4934-4941.2005.
Choi MH, Choe YH, Lee SG, Jeong SH, Kim JH. Neutropenia is independently associated with sub-therapeutic serum concentration of vancomycin. Clin Chim Acta. 2017 Feb;465:106-111. doi: 10.1016/j.cca.2016.12.021. Epub 2016 Dec 23.
Bosso JA, Nappi J, Rudisill C, Wellein M, Bookstaver PB, Swindler J, Mauldin PD. Relationship between vancomycin trough concentrations and nephrotoxicity: a prospective multicenter trial. Antimicrob Agents Chemother. 2011 Dec;55(12):5475-9. doi: 10.1128/AAC.00168-11. Epub 2011 Sep 26.
Taghizadeh-Ghehi M, Rezaee S, Gholami K, Hadjibabaie M. Predictive performance of Vancomycin population pharmacokinetic models in Iranian patients underwent hematopoietic stem cell transplantation. J Res Pharm Pract. 2015 Jul-Sep;4(3):129-34. doi: 10.4103/2279-042X.162357.
Monteiro JF, Hahn SR, Goncalves J, Fresco P. Vancomycin therapeutic drug monitoring and population pharmacokinetic models in special patient subpopulations. Pharmacol Res Perspect. 2018 Jul;6(4):e00420. doi: 10.1002/prp2.420.
Other Identifiers
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2021-2482
Identifier Type: -
Identifier Source: org_study_id
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