Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin

Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin

Sponsors

Lead sponsor: National University Hospital, Singapore

Collaborator: Tan Tock Seng Hospital

Source National University Hospital, Singapore
Brief Summary

This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.

This study will recruit 220 subjects from 2 hospitals over a period of 3 years.

Participants are invited if they have an infection that requires prolonged vancomycin therapy (> more than 10 days).

Overall Status Unknown status
Start Date October 2012
Completion Date September 2015
Primary Completion Date September 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
nephrotoxicity occurring any time while on vancomycin treatment up to 14 days post treatment completion
Secondary Outcome
Measure Time Frame
biomarkers for detection of early nephrotoxicity measured weekly from the date of randomization until 14 days post completion of vancomycin
Enrollment 220
Condition
Intervention

Intervention type: Drug

Intervention name: continuous vancomycin infusion

Description: 24-hour continuous infusion of vancomycin

Arm group label: continuous vancomycin infusion

Intervention type: Drug

Intervention name: intermittent vancomycin infusion

Arm group label: intermittent vancomycin infusion

Eligibility

Criteria:

Inclusion Criteria:

- Adults aged 21-80 years

- Documented infection requiring prolonged (> 10 days) of vancomycin therapy

- Creatinine clearance > 50 ml/min (using Cockroft-Gault equation)

Exclusion Criteria:

- Patient already received 7 days or more of vancomycin therapy

- Pregnancy

- Severe burns > 40% body surface area

- Spinal cord injuries

- Participation in another interventional trial in previous 30 days

- Inability to obtain informed consent

Gender: All

Minimum age: 21 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Contact

Last name: Shire Yang Tan

Phone: 97989001

Email: [email protected]

Location
facility status contact investigator National University Hospital Shire Yang Tan 97989001 [email protected] Dale Fisher Principal Investigator
Location Countries

Singapore

Verification Date

November 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: National University Hospital, Singapore

Investigator full name: Medicine

Investigator title: Division of Infectious Diseases

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: continuous vancomycin infusion

Arm group type: Experimental

Arm group label: intermittent vancomycin infusion

Arm group type: Active Comparator

Description: vancomycin in this arm will be administered as intermittent infusion

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov