Clinical trial NCT02896218: Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry
Official title: Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Keywords: Vancomycin
Critically Ill
Pharmacist
Population Pharmacokinetic
Bayesian Methods
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Detailed description: 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). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. 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. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The rate of treatment failure
timeFrame: 2016-9 to 2018-1
Secondary outcomes:
measure: All cause mortality
timeFrame: 2016-9 to 2018-1
measure: Mortality caused by infections
timeFrame: 2016-9 to 2018-1
measure: Mortality caused by gram-positive infections
timeFrame: 2016-9 to 2018-1
measure: Adverse events related to vancomycin
timeFrame: 2016-9 to 2018-1
measure: Nephrotoxicity related to vancomycin
timeFrame: 2016-9 to 2018-1
measure: Cost-effectiveness of pharmacist intervention
timeFrame: 2016-9 to 2018-1
measure: Duration of using ventilator
timeFrame: 2016-9 to 2018-1
measure: Vancomycin dosage
timeFrame: -2016-9 to 201
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qinggang Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.