Ceftazidime-Avibactam Contemporary Use and Evaluation of Time to Appropriate Therapy for Gram-Negative Infections: A Multicenter Observational Study

Abstract Study Design This will be a retrospective multicenter cohort study conducted at a minimum of 12 medical centers and include 10 geographically distinct sites overall. Data will be collected by retrospective chart reviews using an electronic data collection form (REDCap). The study is to be supported by grant funding from AbbVie. Institutional Review Boards at each participating site will review this study prior to commencement. Inclusion and Exclusion All hospitalized patients ≥18 years of age with suspected or confirmed Gram-negative infection of any source who received CAZ-AVI for ≥72 hours from June 1, 2019 to December 31, 2022 will be included in this study. Patients will be excluded if they transferred in from a separate healthcare system with positive Gram-negative cultures also from an outside facility, were pregnant or a prisoner, or had subsequent CAZ-AVI courses unless separated by 60 days from index culture. Data Collection The electronic medical record will be accessed and the following data will be extracted retrospectively after the patient has been discharged: demographics, medical history, comorbidity burden estimated by the Carlson Comorbidity Index (CCI), patient severity described by the Acute Physiology and Chronic Health Evaluation II (APACHE II) score with the most severe patient values taken 24 hours around index culture and Sequential Organ Failure Assessment (SOFA) score, risk factors for MDR acquisition, clinical laboratory data, microbiological data, infection source, and treatment-related parameters including dosage and duration of all antimicrobial therapies with documented in-vitro susceptibility for the index culture. Study data will be collected and managed using the Research Electronic Data Capture (REDCap) tool hosted at Wayne State University. REDCap is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.16 The full case reporting form is displayed in Appendix 1. Sites will be selected based on their ability to provide complete data. Data is to be extracted and entered by collaborators at each institution involved. Data will be reviewed by investigators for completeness and accuracy, and each institution will be instructed by investigators to fill-in any missing information or variables. Any final case that has missing information related to the primary analysis (composite outcome as defined below) will be excluded. Use of Protected Health Information (HPI) will be limited to DMC/HFH MRN and elements of dates which will be kept on a password-protected master list kept behind the secure DMC Citrix server. Only de-identified information will be stored in REDCap data collection database for analysis.