Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

NCT02896218 | Unknown DMC

• 1 other identifier: CM-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

Conditions

Critically Ill

Keywords

Vancomycin; Critically Ill; Pharmacist; Population Pharmacokinetic; Bayesian Methods

Outcome Measures

Primary Outcomes (1)

• The rate of treatment failure

  2016-9 to 2018-1

Secondary Outcomes (8)

• All cause mortality

  2016-9 to 2018-1

• Mortality caused by infections

  2016-9 to 2018-1

• Mortality caused by gram-positive infections

  2016-9 to 2018-1

• Adverse events related to vancomycin

  2016-9 to 2018-1

• Nephrotoxicity related to vancomycin

  2016-9 to 2018-1

Study Arms (2)

Pharmacist consulting group

When physicians make the decision that patients need to prescribe vancomycin or need dose adjustment, they will call for a pharmacist consultation. Pharmacists will provide the initial regimen based on PPK methods if applicable, otherwise give the suggestion of the initial dosage according to guidelines. Also, pharmacists will give suggestions on the time of sampling for serum concentration measurement. For dosage adjustment, pharmacists will be informed the results of serum vancomycin concentration, and then make a calculation using Bayesian estimation to determine whether there is a necessity to change the dosing regimen. Pharmacists will follow the patients until they discharge.

Other: Pharmacists consultation

Usual care group

Empirical use of vancomycin without pharmacists consultation.

Interventions

Pharmacists consultation OTHER

Pharmacists consultation of vancomycin individualized dosing strategy

Pharmacist consulting group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The prospective cohort: all patients in this cohort will receive pharmacist consultation when prescribed vancomycin. The retrospective cohort: patients in this cohort received usual care from JAN 2010 to MAR 2015; patients in this cohort received pharmacist consultation from APR 2016 to JUL 2016.

You may qualify if:

• Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN 2010.
• Receiving vancomycin therapy for 72 hours or more.
• Aged ≥ 18 years.

You may not qualify if:

• Administration of vancomycin in non-intravenous access.
• Life expectancy of less than 24 hours.
• Pregnancy women.
• Presence of immunodeficiency.
• Presence of hematological disorder.
• Written informed consent not obtained in the prospective cohort.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (5)

• Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC Jr, Craig WA, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adults summary of consensus recommendations from the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2009 Nov;29(11):1275-9. doi: 10.1592/phco.29.11.1275.

  PMID: 19873687 BACKGROUND

• Ye ZK, Chen YL, Chen K, Zhang XL, Du GH, He B, Li DK, Liu YN, Yang KH, Zhang YY, Zhai SD; Guideline Steering Group, the Guideline Development Group and the Guideline Secretary Group. Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. J Antimicrob Chemother. 2016 Nov;71(11):3020-3025. doi: 10.1093/jac/dkw254. Epub 2016 Jul 11.

  PMID: 27494905 BACKGROUND

• Matsumoto K, Takesue Y, Ohmagari N, Mochizuki T, Mikamo H, Seki M, Takakura S, Tokimatsu I, Takahashi Y, Kasahara K, Okada K, Igarashi M, Kobayashi M, Hamada Y, Kimura M, Nishi Y, Tanigawara Y, Kimura T. Practice guidelines for therapeutic drug monitoring of vancomycin: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. J Infect Chemother. 2013 Jun;19(3):365-80. doi: 10.1007/s10156-013-0599-4. Epub 2013 May 15. No abstract available.

  PMID: 23673472 BACKGROUND

• Pea F, Bertolissi M, Di Silvestre A, Poz D, Giordano F, Furlanut M. TDM coupled with Bayesian forecasting should be considered an invaluable tool for optimizing vancomycin daily exposure in unstable critically ill patients. Int J Antimicrob Agents. 2002 Nov;20(5):326-32. doi: 10.1016/s0924-8579(02)00188-7.

  PMID: 12431867 BACKGROUND

• Smith C, Burley C, Ireson M, Johnson T, Jordan D, Knight S, Mason T, Massey D, Moss J, Williams K. Clinical trials of antibacterial agents: a practical guide to design and analysis. Statisticians in the Pharmaceutical Industry Working Party. J Antimicrob Chemother. 1998 Apr;41(4):467-80. doi: 10.1093/jac/41.4.467.

  PMID: 9598778 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qinggang Ge, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinggang Ge, M.D.

CONTACT

qingganggelin@126.com

Yingying YAN, Ph.D.

CONTACT

yanyingying89@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Chief physician

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 12, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)