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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014