Recruiting
Phase 4

Antibiotic Combinations

Sponsor:

Bassett Healthcare

Code:

NCT07556107

Conditions

Infection

Acute Kidney Injury

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Piperacillin + Tazobactam

meropenem

Study Details

Brief 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

Infection

Acute Kidney Injury

Sepsis

Study ID

NCT07556107

Start date

Aug 17, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

852 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Piperacillin/tazobactam

Vancomycin plus piperacillin/tazobactam

active comparator: Meropenem

Vancomycin plus meropenem

Interventions

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

meropenem

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.

Primary outcome measure

  • Serum cystatin C (Scys) [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Jennifer Victory, RN, CCRC

607-547-6965jennifer.victory@bassett.org

Aletha Sprague

aletha.sprague@bassett.org

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-1150

Contacts

Brooklin Zimmerman

402-559-5237brooklin.zimmerman@unmc.edu

Principal Investigator:

Aaron Barksdale, MD

Bassett Medical Center

Recruiting

Cooperstown, New York, United States, 13326

Contacts

Jennifer Victory

6075476965jennifer.victory@bassett.org

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Karen Ayala Baylon

(336) 716-5044Karen.Ayalabaylon@Advocatehealth.org

Christine Rogers

(336) 716-3978christine.rogers2@advocatehealth.org

Principal Investigator:

John Williamson, PharmD

Medical University of South Carolina - South Carolina Clinical & Translational Research Institute

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Della MacNicholas

843-792-8385macnichd@musc.edu

Principal Investigator:

John McKinnon, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Karen Hunter

(304) 293-7348karen.hunter@hsc.wvu.edu

Principal Investigator:

Daphne-Dominique Villanueva, MD

More Information

Sponsor

Bassett Healthcare

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • infection
  • hospitalized
  • AKI
  • cystatin c
  • vancomycin
  • piperacillin/tazobactam
  • meropenem
  • RCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Bassett Healthcare on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.