Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
Conditions
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).
Interventions
24-hour continuous infusion of vancomycin
DRUGintermittent vancomycin infusion
Sponsors
Tan Tock Seng Hospital
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nephrotoxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| biomarkers for detection of early nephrotoxicity | measured weekly from the date of randomization until 14 days post completion of vancomycin | serum and urine NGAL and cystatin C |
Countries
Singapore
Contacts
Primary ContactShire Yang Tan
Outcome results
None listed