A Randomized Controlled Trial Comparing Renal Effects of Vancomycin Combined With Either Piperacillin/Tazobactam or Meropenem: VPT Patient Safety (VPS) Study
Bassett Healthcare
Summary
The VPT Safety Trial (VPS) compares two common antibiotic combinations to see how they affect the kidneys of patients in the hospital with serious infections. Both combinations are approved by the Food and Drug Administration (FDA). The goal is to help doctors know which combination is safer so they can make better choices for their patients.
Description
* What is the study's main question? Does the antibiotic combination vancomycin and piperacillin/tazobactam (VPT) cause kidney problems (acute kidney injury or AKI)? * What is the Background to the Research Question? VPT is the most common antibiotic combination used for patients in the hospital with serious infections. Some studies using a standard kidney blood test (creatinine) show more kidney problems (AKI) with VPT than with other antibiotic combinations, but these studies are not always very accurate. Because of this, some doctors use other combinations like vancomycin and cefepime (VC)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria 1. Hospitalized or being hospitalized. 2. Age \>/=18 yr old. 3. Serious or suspected serious infection for which VPT or VM considered a broad-spectrum combination antibiotic backbone standard of care by clinician. 4. Enrollment can be completed before the first dose of abx (ideally) and no later than before the second dose (alternatively). 5. Consenting/enrollment will not clinically significantly delay abx administration. 6. Baseline and \>/=1 prior Scr available (within 1 yr). 7. Pt or LAR able to provide IC. Exclusion criteria 1\. AKI (\>/=moderate) (KDIGO stage 2-3) (S…
Interventions
- DrugPiperacillin + Tazobactam
PT Dosing (concealed): PT dosing is standard irrespective of infection severity. 4.5 gm IV loading dose over 30 min, then 4.5 g IV over 4 hr (extended infusion) 6 hrs after the loading dose, and then q 8 hr
- Drugmeropenem
M dosing (concealed): M dosing depends on infection severity. 1 gm loading IV dose over 30 min, then 1 gm IV over 4 hr (extended infusion) q 8 hr (default dosing). Clinician has option to increase to 2 gm IV q 8 hr for severe infections and to decrease back to default dosing if previously chosen higher dosing is no longer deemed indicated.
Location
- Bassett Medical CenterCooperstown, New York