RESEARCH

The major goal of this project is to characterize and estimate the probability of antibiotic resistance among adult patients with complicated urinary tract infections (cUTIs) in the outpatient setting, as well as characterize cUTI patients who are at risk for treatment failure.

The objectives of this large retrospective data-only study are to use two parallel study designs to assess the VE of Pfizer COVID-19 vaccine against 2 primary endpoints: 1.) Severe outcomes (COVID-19 associated hospitalization, ICU admission, and death); and 2.) Outpatient laboratory-confirmed COVID-19 diagnosis.

Respiratory Syncytial Virus (RSV) is a major cause of respiratory infection for infants and older adults. In this study, we will estimate vaccine effectiveness of Pfizer’s RSVpreF vaccine against RSV-related lower respiratory tract infection requiring hospitalization among KPSC older adults who are eligible for vaccination per current ACIP recommendations.

The purpose of this study is to provide critical information about the predictors of severe RSV disease, describe epidemiology and burden of hospitalized RSV disease in older adults, and assess healthcare utilization associated with hospitalized RSV disease in older adults in a community setting. A population of hospitalized older adults testing positive for influenza will also be identified for comparison purposes.

The overall goal of this feasibility work will be to develop a protocol for the main outpatient C. difficile study that will achieve the goals of the retrospective, prospective, and validation components outlined by the funder.

Comparative vaccine effectiveness of influenza vaccine in the 2022-2023 season.

Elevated tissue and serum levels of IL-6 have been implicated in the disease pathology of several inflammatory and autoimmune disorders including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), and cytokine-release syndrome (CRS). Tocilizumab or TCZ (Actemra) is a recombinant humanized, anti-human monoclonal antibody directed against soluble and membrane-bound IL-6R. On March 3rd 2020, TCZ was included in the updated diagnosis and treatment plan for COVID-19 issued by the China National Health Commission as one treatment option for severe or critical forms of COVID-19 pneumonia. However, despite fairly widespread use in China, Actemra has not received health authority approval for COVID-19 in any country. More robust clinical evidence regarding the safety or efficacy of TCZ in the treatment of COVID-19 is needed. Roche is conducting a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of TCZ in combination with SOC compared with matching placebo in combination with SOC in hospitalized adult patients with severe COVID-19 pneumonia (n=330). KPSC is collecting demographic, comorbidity, and clinical information on KPSC patients hospitalized with COVID-19 infection to create a real world data (RWD) comparator arm that will be matched to the TCZ treatment arm of the RCT.