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

Infections Requiring Prolonged Duration (>10 Days) of Vancomycin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01720940
• Other study ID #: NUHID-001
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2012
• Last updated: November 1, 2012
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2012
• Source: National University Hospital, Singapore
• Contact: Shire Yang Tan
• Phone: 97989001
• Email: shire_yang_tan[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review BoardsSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infections Requiring Prolonged Duration (>10 Days) of Vancomycin

Intervention

Drug:
• continuous vancomycin infusion
24-hour continuous infusion of vancomycin
• intermittent vancomycin infusion

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nephrotoxicity	nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria	occurring any time while on vancomycin treatment up to 14 days post treatment completion	Yes
Secondary	biomarkers for detection of early nephrotoxicity	serum and urine NGAL and cystatin C	measured weekly from the date of randomization until 14 days post completion of vancomycin	No