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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
Information provided by (Responsible Party):

October 21, 2012
November 2, 2012
November 2, 2012
October 2012
September 2015   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin
Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin

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).

Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
  • Drug: continuous vancomycin infusion
    24-hour continuous infusion of vancomycin
  • Drug: intermittent vancomycin infusion
  • Experimental: continuous vancomycin infusion
    Intervention: Drug: continuous vancomycin infusion
  • Active Comparator: intermittent vancomycin infusion
    vancomycin in this arm will be administered as intermittent infusion
    Intervention: Drug: intermittent vancomycin infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2015
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Medicine, National University Hospital, Singapore
National University Hospital, Singapore
Tan Tock Seng Hospital
Not Provided
National University Hospital, Singapore
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP