COOPERSTOWN, N.Y. — Bassett Research Institute in Cooperstown will use about $12 million in grant funding to launch a study about the effects on the kidneys of a common antibiotic regimen used to treat hospitalized patients with severe infections.
The Washington, D.C.–based Patient-Centered Outcomes Research Institute (PCORI) awarded the money, Bassett said.
Conducted in real-world care settings, the study will generate evidence on outcomes that matter most to patients, helping them and their clinicians make better-informed decisions, per the Wednesday announcement. The project aims to resolve a decision-making challenge that clinicians routinely face when deciding what antibiotics to prescribe.
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Dr. Daniel Freilich, medical director of the Center for Clinical Research at the Bassett Research Institute, will lead the effort.
The research is co-led by Dr. Daniel Hanley, director of the Brain Injury Outcomes (BIOS) Clinical Trials Coordinating Center at Johns Hopkins University in Baltimore, Maryland.
Other key sites on study leadership committees include Oregon Health and Science University in Portland, Oregon; the Wake Forest School of Medicine in Winston-Salem, North Carolina; West Virginia University in Morgantown, West Virginia; and the University of Pittsburgh.
Antibiotic regimen VPT
As the Bassett Research Institute explains it, the antibiotic regimen the study will analyze is the combination of vancomycin and piperacillin/tazobactam (VPT). VPT has long been considered a standard treatment approach for hospitalized patients diagnosed with severe infections.
Studies have been conducted in the past to assess the effects of these medications on the kidneys. Most have shown more acute kidney injury with VPT than with other combinations of antibiotics, like vancomycin and cefepime or vancomycin and meropenem. As a result, some experts have recommended use of these alternate non-VPT regimens to avoid kidney injury (though the alternate regimens have their own potential side effects, including brain toxicity, multidrug resistant colonization and infections, and C diff infection).
Other trials have suggested VPT may not cause significant acute kidney injury at all, leading to the current challenges clinicians face when making the best recommendations to their patients when choosing an effective treatment for infection.
Bassett Research Institute’s study will seek to confirm its hypothesis that kidney function is not different among hospitalized patients with serious infections treated by VPT compared to non-VPT antibiotic therapy. Testing serum cystatin C as the study’s primary outcome, a more accurate, state-of-the-art kidney function test than the standard one, creatinine, and uniquely testing kidney urine injury markers, the study will provide a thorough understanding of kidney effects in patients treated with VPT versus the non-VPT antibiotic therapy.
“The results of this study aim to help hospitalized patients by improving the quality of their care, their safety, and potentially decreasing complications they may encounter. It aims to help specialty organizations that write clinical practice guidelines by giving them information to update protocols and stop variance in practice due to the current gap in information. It also helps healthcare systems and insurers implement standards for best practices for antibiotics therapy in hospitalized patients” Freilich said. “We thank PCORI for their investment in our work and we look forward to conducting this study and sharing our findings.”
