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RECRUITING Phase 4 ClinicalTrials.gov

The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)

Sponsor: Bassett Healthcare • ClinicalTrials.gov ID: NCT07556107

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Piperacillin + Tazobactam (Drug)
    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
  • meropenem (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.

Eligibility criteria

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) (Scr increase \>/=2-fold from chronic BL) (Scr based). 2\. CKD (\>/=moderately to severely decreased eGFR) (KDIGO stage G3b-G5) (by history or eGFR \</=44 mL/min/1.73M2) (Scr based). 3\. Beta lactam allergy. 4. Contraindication to VPT or VM. 5. Infection requiring VPT or VM specifically or another abx regimen. 6. Participation in another research study with interventions that may impact study endpoints.

Conditions

Infection Acute Kidney Injury Sepsis

Locations

  • University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Bassett Medical Center — Cooperstown, New York, United States
  • NY Presbyterian/Queens — Flushing, New York, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Medical University of South Carolina - South Carolina Clinical & Translational Research Institute — Charleston, South Carolina, United States
  • West Virginia University — Morgantown, West Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record