VPS seeks to definitively answer the question whether VPT causes kidney toxicity. VPS will provide clinicians and patients with robust evidence to improve decision making and quality of life.
The antibiotics combination vancomycin and piperacillin/tazobactam (VPT) is the workhorse for treatment of serious infections in US hospitals. However, most clinical studies suggest the combination causes acute kidney injury (AKI) (kidney toxicity), and thus many experts suggest clinicians avoid its use when possible. But such modification of clinical care comes at a cost, with alternatives causing other toxicities and complications. The investigators propose conducting the VPT Patient Safety (VPS) randomized clinical trial (RCT), at 23-33 US hospitals aiming to comprehensively compare ‘kidney health’ in hospitalized patients with serious infections treated with VPT in comparison with another standard antibiotic combination. VPS is unique in that it will be the first multicenter RCT on the topic and the first to thoroughly study VPT’s effects on the kidneys using state-of-the-art much more accurate kidney function and injury biomarkers. VPS will result in significant updating of clinical practice guidelines and clinical care in the hospitals and improve patient safety, and likely lead to decreased morbidity and mortality and improved quality of life for hospitalized patients with serious infections.
The investigators would like 4-6 patient/family partners to provide perspectives and decision making on leadership committees via zoom meetings conducted 2-3 times a year over 4 years. Patient partners can expect to serve as equal voting members, helping to optimize study design protocol and informed consent, conduct and safety, analysis and reporting as well as involvement in implementation and dissemination of the study results.
The investigators are seeking people who: · Are patients, family members and/or caregivers who are affected by kidney disease or kidney injury (which makes them vulnerable to kidney damage when using certain antibiotics) OR · Patients, family members, and/or caregivers who have dealt directly or indirectly with sepsis, and or hospitalization for serious infections treated with antibiotics. OR · Patients, family members or caregivers who deal with complicated disease processes, i.e. immuno compromised, chronic conditions (autoimmune, viral etc.) that result in hospitalizations to treat serious infections.
Proposal in development
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