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

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ClinicalTrials.gov Identifier: NCT01720940
Recruitment Status : Unknown
Verified November 2012 by Medicine, National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : November 2, 2012
Last Update Posted : November 2, 2012
Sponsor:
Collaborator:
Tan Tock Seng Hospital
Information provided by (Responsible Party):
Medicine, 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).


Condition or disease Intervention/treatment Phase
Infections Requiring Prolonged Duration (>10 Days) of Vancomycin Drug: continuous vancomycin infusion Drug: intermittent vancomycin infusion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin
Study Start Date : October 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. nephrotoxicity [ Time Frame: 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 :
  1. biomarkers for detection of early nephrotoxicity [ Time Frame: measured weekly from the date of randomization until 14 days post completion of vancomycin ]
    serum and urine NGAL and cystatin C



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medicine, Division of Infectious Diseases, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01720940     History of Changes
Other Study ID Numbers: NUHID-001
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents