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

ConditionsInfection Acute Kidney Injury Sepsis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorBassett Healthcare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalized or being hospitalized.

Age >/=18 yr old.

Serious or suspected serious infection for which VPT or VM considered a broad-spectrum combination antibiotic backbone standard of care by clinician.

Enrollment can be completed before the first dose of abx (ideally) and no later than before the second dose (alternatively).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

852 Participants

are divided into 2 treatment groups

Group A: Piperacillin/tazobactamActive comparator 1 intervention

Group B: MeropenemActive comparator 1 intervention

Trial outcomes

Primary outcomes

Serum cystatin C (Scys)

Difference between highest Scys (mg/L) post-treatment over 7 days minus Scys pre-treatment, expressed as ratio of pre-treatment level

Time frame

7 days

Secondary outcomes

Acute Kidney injury (AKI)/death

AKI/death KDIGO ADQI stages 0-4 (expanded with injury biomarkers) (Scr-Scys, Scys, Scr based) (transient \<72 vs. persistent \>72 hr) rate

Time frame

7 days

Infectious complications

MDR (MRSA, VRE, ESBL, CRE)/fungal/CDI rate

Time frame

90 days

Other outcomes

serum creatinine (Scr)

Difference between highest Scr (mg/L) post-treatment over 7 D minus Scr pre-treatment, expressed as ratio of pre-treatment level

Time frame

7 days

Kidney Injury biomarkers

NGAL, TIMP-2×IGFBP7, KIM-1, ACR

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bassett Healthcare

Lead sponsor

Johns Hopkins University

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

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