Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

Critically Ill Clinical Trial

— VCMTDMinCI  

Official title:

Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02896218
• Other study ID #: CM-001
• Status: Recruiting
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Peking University Third Hospital
• Contact: Qinggang Ge, M.D.
• Email: qingganggelin[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• Pharmacists consultation
Pharmacists consultation of vancomycin individualized dosing strategy

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. Epub 2016 Jul 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of treatment failure		2016-9 to 2018-1
Secondary	All cause mortality		2016-9 to 2018-1
Secondary	Mortality caused by infections		2016-9 to 2018-1
Secondary	Mortality caused by gram-positive infections		2016-9 to 2018-1
Secondary	Adverse events related to vancomycin		2016-9 to 2018-1
Secondary	Nephrotoxicity related to vancomycin	According to KDIGO, AKI is defined by any of the following: Increase in serum creatinine by =0.3 mg/dL (=26.5 micromol/L) within 48 hours; or; Increase in serum creatinine to =1.5 times baseline, which is known or presumed to have occurred within the prior seven days; or; Urine volume <0.5 mL/kg/h for six hours.; All adverse events will be assessed and analyzed with WHO-UMC causality criteria by investigators. Adverse events related to vancomycin, especially nephrotoxicity, will be analyzed.	2016-9 to 2018-1
Secondary	Cost-effectiveness of pharmacist intervention	The outcome is the incremental cost of preventing one treatment failure infection-related mortality or nephrotoxicity.	2016-9 to 2018-1
Secondary	Duration of using ventilator		2016-9 to 2018-1
Secondary	Vancomycin dosage		-2016-9 to 201