The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)
NCT07556107 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 852
Last updated 2026-04-29
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.
Conditions
Interventions
- DRUG
-
Piperacillin + 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
- DRUG
-
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.
Sponsors & Collaborators
- collaborator OTHER
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Bassett Healthcare
lead OTHER
Principal Investigators
-
Daniel Freilich, MD · Bassett Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2028-06-30
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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