ClinicalTrials.gg
RecruitingNCT07556107VPSUpdated Oct 15, 2026

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

A Phase 4 interventional study of Piperacillin + Tazobactam and meropenem in Infection, Acute Kidney Injury and Sepsis, sponsored by Bassett Healthcare. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Primary conditionSepsisRegistry: InfectionsReclassifiedWhy we changed it
Registry
Infections — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sepsis
Why
  1. The study's listed conditions name Sepsis, a narrower term within Infections.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Bassett Healthcare · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 15, 20264 sites addedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
852
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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) or vancomycin and meropenem (VM). However, these other combinations may have their own risks, like infections that are hard to treat, serious diarrhea, higher cost, or problems with the brain. One study used a better kidney blood test (cystatin C) and did not find more kidney problems with VPT. Another more accurate type of study (randomized clinical trial) also did not find more kidney problems with VPT, but some people did not agree with how that study was done. So, doctors are still not sure if VPT causes more kidney problems, or if they should use VPT or another antibiotic combination for patients in the hospital with serious infections.
  • Why is AKI important? AKI is important because people who get it may have more heart and kidney problems, might need dialysis, stay in the hospital longer, have more hospital visits, higher costs, and a higher chance of death. Avoiding AKI can help prevent these problems.
  • How will this study help answer the question? VPS is a randomized study, which is usually more accurate, and uses a better kidney function blood test (cystatin C). The results will help doctors make better guidelines, improve care, and keep patients safer.
  • What are the goals of VPS? The main goal is to find out if VPT really causes kidney problems, so doctors can choose the best antibiotics for patients with serious infections. The study will look at differences in a special kidney blood test (cystatin C) between patients getting VPT and those getting VM. Other goals are to compare things like kidney problems, infections, how long patients stay in the hospital, repeat hospital visits, if patients need a breathing machine or medicine for low blood pressure, quality of life, and death rates.
02

Conditions studied

  • Infection
  • Acute Kidney Injury
  • Sepsis

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Keywords

  • infection
  • hospitalized
  • AKI
  • cystatin c
  • vancomycin
  • piperacillin/tazobactam
  • meropenem
  • RCT
03

In context

Sepsis Reclassified

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 852 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Bassett Healthcare is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Compared within Sepsis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 ) (KDIGO stage G3b-G5) (by history or eGFR \</=44 mL/min/1.73M2) (Scr based).

3. Beta lactam allergy. 4. 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
852 participants (estimated)

Study arms

  • Active comparator
    Piperacillin/tazobactam

    Vancomycin plus piperacillin/tazobactam

    Drug: Piperacillin + Tazobactam

  • Active comparator
    Meropenem

    Vancomycin plus meropenem

    Drug: meropenem

Interventions

  • DrugPiperacillin + Tazobactam

    Drug pages: 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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Infectious complications

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

    Time frame: 90 days

Other outcomes

  1. 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

  2. Kidney Injury biomarkers

    NGAL, TIMP-2×IGFBP7, KIM-1, ACR

    Time frame: 90 days

07

Study locations

5 of 7 sites recruiting
08

References and documents

Publications

  • Miano TA, Hennessy S, Yang W, Dunn TG, Weisman AR, Oniyide O, Agyekum RS, Turner AP, Ittner CAG, Anderson BJ, Wilson FP, Townsend R, Reilly JP, Giannini HM, Cosgriff CV, Jones TK, Meyer NJ, Shashaty MGS. Association of vancomycin plus piperacillin-tazobactam with early changes in creatinine versus cystatin C in critically ill adults: a prospective cohort study. Intensive Care Med. 2022 Sep;48(9):1144-1155. doi: 10.1007/s00134-022-06811-0. Epub 2022 Jul 14. PubMed 35833959 ↗
  • Rahman M, Shad F, Smith MC. Acute kidney injury: a guide to diagnosis and management. Am Fam Physician. 2012 Oct 1;86(7):631-9. PubMed 23062091 ↗
  • Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X. PubMed 15811456 ↗
  • FDA. Pfizer Injectables. ZOSYN (piperacillin and tazobactam) for injection. 2017. Accessed November 12, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf
  • Qian ET, Casey JD, Wright A, Wang L, Shotwell MS, Siemann JK, Dear ML, Stollings JL, Lloyd BD, Marvi TK, Seitz KP, Nelson GE, Wright PW, Siew ED, Dennis BM, Wrenn JO, Andereck JW, Han JH, Self WH, Semler MW, Rice TW; Vanderbilt Center for Learning Healthcare and the Pragmatic Critical Care Research Group. Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized With Acute Infection: The ACORN Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1557-1567. doi: 10.1001/jama.2023.20583. PubMed 37837651 ↗
  • Cote JM, Desjardins M, Murray PT. Does Vancomycin-Piperacillin-Tazobactam Cause Pseudo-AKI, True Nephrotoxicity, or Both? Chest. 2023 Aug;164(2):273-274. doi: 10.1016/j.chest.2023.05.009. No abstract available. PubMed 37558318 ↗
  • Blair M, Cote JM, Cotter A, Lynch B, Redahan L, Murray PT. Nephrotoxicity from Vancomycin Combined with Piperacillin-Tazobactam: A Comprehensive Review. Am J Nephrol. 2021;52(2):85-97. doi: 10.1159/000513742. Epub 2021 Mar 18. PubMed 33735856 ↗
  • Kimball JM, Deri CR, Nesbitt WJ, Nelson GE, Staub MB. Development of the Three Antimicrobial Stewardship E's (TASE) Framework and Association Between Stewardship Interventions and Intended Results Analysis to Identify Key Facility-Specific Interventions and Strategies for Successful Antimicrobial Stewardship. Clin Infect Dis. 2021 Oct 20;73(8):1397-1403. doi: 10.1093/cid/ciab430. PubMed 33983389 ↗
  • Downes KJ, Laskin BL, Fisher BT. The Cost of Vancomycin and Piperacillin/Tazobactam Treatment-Reply. JAMA Pediatr. 2018 May 1;172(5):494-495. doi: 10.1001/jamapediatrics.2018.0038. No abstract available. PubMed 29507935 ↗
  • Goodman KE, Cosgrove SE, Pineles L, Magder LS, Anderson DJ, Dodds Ashley E, Polk RE, Quan H, Trick WE, Woeltje KF, Leekha S, Harris AD. Significant Regional Differences in Antibiotic Use Across 576 US Hospitals and 11 701 326 Adult Admissions, 2016-2017. Clin Infect Dis. 2021 Jul 15;73(2):213-222. doi: 10.1093/cid/ciaa570. PubMed 32421195 ↗
  • Chen AY, Deng CY, Calvachi-Prieto P, Armengol de la Hoz MA, Khazi-Syed A, Chen C, Scurlock C, Becker CD, Johnson AEW, Celi LA, Dagan A. A Large-Scale Multicenter Retrospective Study on Nephrotoxicity Associated With Empiric Broad-Spectrum Antibiotics in Critically Ill Patients. Chest. 2023 Aug;164(2):355-368. doi: 10.1016/j.chest.2023.03.046. Epub 2023 Apr 9. PubMed 37040818 ↗
  • Alosaimy S, Lagnf AM, Hobbs ALV, Mubarez M, Kufel WD, Morrisette T, Polisetty RS, Li D, Veve MP, Simon SP, Truong J, Finch N, Venugopalan V, Rico M, Amaya L, Yost C, Cubillos A, Chandler E, Patch M, Smith IMK, Biagi M, Wrin J, Moore WJ, Molina KC, Rebold N, Holger D, Kunz Coyne AJ, Jorgensen SCJ, Witucki P, Tran NN, Davis SL, Sakoulas G, Rybak MJ. Nephrotoxicity of Vancomycin in Combination With Beta-Lactam Agents: Ceftolozane-Tazobactam vs Piperacillin-Tazobactam. Clin Infect Dis. 2023 Feb 8;76(3):e1444-e1455. doi: 10.1093/cid/ciac670. PubMed 35982631 ↗
  • Hammond DA, Smith MN, Painter JT, Meena NK, Lusardi K. Comparative Incidence of Acute Kidney Injury in Critically Ill Patients Receiving Vancomycin with Concomitant Piperacillin-Tazobactam or Cefepime: A Retrospective Cohort Study. Pharmacotherapy. 2016 May;36(5):463-71. doi: 10.1002/phar.1738. Epub 2016 Apr 1. PubMed 26952639 ↗
  • Giuliano CA, Patel CR, Kale-Pradhan PB. Is the Combination of Piperacillin-Tazobactam and Vancomycin Associated with Development of Acute Kidney Injury? A Meta-analysis. Pharmacotherapy. 2016 Dec;36(12):1217-1228. doi: 10.1002/phar.1851. Epub 2016 Nov 28. PubMed 27805728 ↗
  • Hammond DA, Smith MN, Li C, Hayes SM, Lusardi K, Bookstaver PB. Systematic Review and Meta-Analysis of Acute Kidney Injury Associated with Concomitant Vancomycin and Piperacillin/tazobactam. Clin Infect Dis. 2017 Mar 1;64(5):666-674. doi: 10.1093/cid/ciw811. Epub 2016 Dec 10. PubMed 27940946 ↗
  • Bellos I, Karageorgiou V, Pergialiotis V, Perrea DN. Acute kidney injury following the concurrent administration of antipseudomonal beta-lactams and vancomycin: a network meta-analysis. Clin Microbiol Infect. 2020 Jun;26(6):696-705. doi: 10.1016/j.cmi.2020.03.019. Epub 2020 Mar 25. PubMed 32222460 ↗
  • Magill SS, Edwards JR, Beldavs ZG, Dumyati G, Janelle SJ, Kainer MA, Lynfield R, Nadle J, Neuhauser MM, Ray SM, Richards K, Rodriguez R, Thompson DL, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Prevalence of antimicrobial use in US acute care hospitals, May-September 2011. JAMA. 2014 Oct 8;312(14):1438-46. doi: 10.1001/jama.2014.12923. PubMed 25291579 ↗
  • Watkins RR, Deresinski S. Increasing Evidence of the Nephrotoxicity of Piperacillin/Tazobactam and Vancomycin Combination Therapy-What Is the Clinician to Do? Clin Infect Dis. 2017 Nov 29;65(12):2137-2143. doi: 10.1093/cid/cix675. PubMed 29020249 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Sites
4 sites added
Show 4 added (4 United States)
  • University of Massachusetts Chan Medical School · Worcester, United States
  • University of Nebraska Medical Center · Omaha, United States
  • NY Presbyterian/Queens · Flushing, United States
  • Medical University of South Carolina - South Carolina Clinical & Translational Research Institute · Charleston, United States
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    4 sites added
    Show 4 added (4 United States)
    • University of Massachusetts Chan Medical School · Worcester, United States
    • University of Nebraska Medical Center · Omaha, United States
    • NY Presbyterian/Queens · Flushing, United States
    • Medical University of South Carolina - South Carolina Clinical & Translational Research Institute · Charleston, United States
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07556107
Lead sponsor
Bassett Healthcare
Collaborators
Johns Hopkins University, Patient-Centered Outcomes Research Institute
Responsible party
Daniel Freilich, MD (Senior Attending Physician, Principal Investigator #1, Bassett Healthcare) — Principal investigator
First posted
Apr 29, 2026
Start date
Aug 17, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 15, 2026

Study contacts

Jennifer Victory, RN, CCRC
Contact
jennifer.victory@bassett.org
607-547-6965
Aletha Sprague
Contact
aletha.sprague@bassett.org
Daniel Freilich, MD
principal investigator · Bassett Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Piperacillin · Tazobactam · Meropenem

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