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

This study is currently recruiting participants.
Verified November 2012 by National University Hospital, Singapore
Sponsor:
Collaborator:
Tan Tock Seng Hospital
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01720940
First received: October 21, 2012
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
Drug: continuous vancomycin infusion
Drug: intermittent vancomycin infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • nephrotoxicity [ Time Frame: occurring any time while on vancomycin treatment up to 14 days post treatment completion ] [ Designated as safety issue: Yes ]
    nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria


Secondary Outcome Measures:
  • biomarkers for detection of early nephrotoxicity [ Time Frame: measured weekly from the date of randomization until 14 days post completion of vancomycin ] [ Designated as safety issue: No ]
    serum and urine NGAL and cystatin C


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: continuous vancomycin infusion Drug: continuous vancomycin infusion
24-hour continuous infusion of vancomycin
Active Comparator: intermittent vancomycin infusion
vancomycin in this arm will be administered as intermittent infusion
Drug: intermittent vancomycin infusion

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720940

Contacts
Contact: Shire Yang Tan 97989001 shire_yang_tan@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Shire Yang Tan    97989001    shire_yang_tan@nuhs.edu.sg   
Principal Investigator: Dale Fisher         
Sponsors and Collaborators
National University Hospital, Singapore
Tan Tock Seng Hospital
  More Information

No publications provided

Responsible Party: Medicine, Division of Infectious Diseases, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01720940     History of Changes
Other Study ID Numbers: NUHID-001
Study First Received: October 21, 2012
Last Updated: November 1, 2012
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014