Which antibiotic combo is safer for kidneys in serious hospital infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The VPS trial compares two FDA-approved antibiotic regimens used for serious infections in hospitalized patients to see if one leads to more acute kidney injury (AKI). It uses kidney function tests, including cystatin C, to assess safety. The study aims to help doctors choose the safer option when treating severe infections in the hospital. Enrollment targets adults with suspected serious infection where VPT or VM could be used, and excludes those with moderate-to-severe preexisting kidney disease or beta-lactam allergy. The trial is conducted at multiple centers and led by Bassett Healthcare with collaboration from Johns Hopkins and PCORI.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• Bassett Medical Center
  Cooperstown, New York, United States Recruiting
• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting
• Medical University of South Carolina - South Carolina Clinical & Translational Research Institute
  Charleston, South Carolina, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting
• University of Massachusetts Chan Medical School
  Worcester, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Daniel Freilich, MD — Bassett Medical Center
• Study coordinator: Jennifer Victory, RN, CCRC
• Email: jennifer.victory@bassett.org
• Phone: 607-547-6965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.