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

Not Applicable

• Conditions: Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
• Interventions: Drug: intermittent vancomycin infusion; Drug: continuous vancomycin infusion

• Registration Number: NCT01720940
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-21
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-01
• Last Update Submitted: 2012-11-01
• Study First Posted: 2012-11-02
• Last Update Posted: 2012-11-02
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent vancomycin infusion	intermittent vancomycin infusion	vancomycin in this arm will be administered as intermittent infusion
continuous vancomycin infusion	continuous vancomycin infusion	-

Primary Outcome Measures

Name	Time	Method
nephrotoxicity	occurring any time while on vancomycin treatment up to 14 days post treatment completion	nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria

Secondary Outcome Measures

Name	Time	Method
biomarkers for detection of early nephrotoxicity	measured weekly from the date of randomization until 14 days post completion of vancomycin	serum and urine NGAL and cystatin C

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore