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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
History of Changes

October 21, 2012
November 1, 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 ] [ Designated as safety issue: Yes ]
nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria
Same as current
Complete list of historical versions of study NCT01720940 on ClinicalTrials.gov Archive Site
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
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
220
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
Both
21 Years to 80 Years
No
Contact: Shire Yang Tan 97989001 shire_yang_tan@nuhs.edu.sg
Singapore
 
NCT01720940
NUHID-001
No
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