913. Analysis of Time to Being Dischargeable in Hospitalized Patients with Community Acquired Pneumonia (CAP) Using Data from the FOCUS Trials
Session: Poster Abstract Session: Respiratory Infections
Friday, October 4, 2013
Room: The Moscone Center: Poster Hall C
  • Forest - Time-to-Being Dischargeable in Hospitalized CAP Patients Using FOCUS Trials_IDWeek.pdf (742.3 kB)
  • Background: While hospital length of stay (LOS) comparisons are difficult to make from Phase III CAP trials, an opportunity exists to draw inferences about potential LOS differences between treatments using surrogate dates for hospital discharge. Criteria of discharging a hospitalized CAP patient are well described in the literature and consistent with FDA definition of clinical success for CAP trials. This study compared time to being dischargeable among hospitalized CAP patients randomized to ceftaroline or ceftriaxone.

    Methods: Data were obtained from FOCUS clinical trials (NCT00621504 and NCT00509106). Based on the Infectious Diseases Society of America (IDSA) and American Thoracic Society (ATS) CAP management guidelines, a post-hoc adjudication algorithm was developed to determine time to being dischargeable. Kaplan-Meier (KM) analyses were conducted and patients were censored at Day 7 if not meeting discharge criteria. Treatment outcomes were stratified by baseline pathogen, Pneumonia Outcomes Research Team (PORT) score, CURB-65 score, trial enrollment (FOCUS I, required one day of macrolide, vs. II, no requirement for macrolide), and renal status.

    Results: Analysis included 1,116 patients (ceftaroline n=562; ceftriaxone n=554) with evaluable data for the IDSA/ATS discharge criteria. Treatment groups were similar at baseline with the exception of more patients in the ceftaroline group having a diagnosis of prior pneumonia. KM analysis showed ceftaroline was associated with a significantly shorter time to meeting dischargeable criteria (p=0.034). Among patients with Gram-positive infection only and patients with PORT score III, ceftaroline was associated with a significantly shorter time to meeting the dischargeable criteria (all p<0.05). Among patients with Streptococcus pneumoniae at baseline, no pathogen at baseline, CURB-65 ≥2, moderate-to-severe renal impairment, and enrollment in FOCUS 1, results were numerically in favor of ceftaroline (all p-values between 0.05-0.07).

    Conclusion: Compared to ceftriaxone, the use of ceftaroline in hospitalized CAP patients is associated with significant shorter time to meeting the criteria of being dischargeable and may be associated with earlier time to hospital discharge.

    Thomas Lodise, PharmD1, Antonio R Anzueto, MD2, Andrew F. Shorr, MD, MPH3, David J. Weber, MD, MPH, FIDSA, FSHEA4, Min Yang, MD, PhD5, Alexander Smith, MS6, Qi Zhao, MD, MPH7, Xing-Yue Huang, BPharm, PhD7 and Thomas M. File Jr., MD, MSc, MACP, FIDSA, FCCP8,9, (1)Albany College of Pharmacy, Albany, NY, (2)The Univ. of Texas Health Science Ctr. At San Antonio, San Antonio, TX, (3)Pulmonary and Critical Care Medicine, Washington Hospital Center, Washington, DC, (4)Division of Infectious Diseases, University of North Carolina At Chapel Hill, Chapel Hill, NC, (5)Analysis Group, Inc., Boston, MA, (6)Cerexa, Inc., Oakland, CA, (7)Forest Research Institute, Jersey City, NJ, (8)Northeast Ohio Medical University, Rootstown, OH, (9)Summa Health System, Akron, OH


    T. Lodise, Forest Research Institute: Investigator, Research grant

    A. R. Anzueto, Forest Research Institute: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium

    A. F. Shorr, Forest Research Institute: Consultant and Scientific Advisor, Consulting fee, Research grant and Speaker honorarium

    D. J. Weber, Pfizer: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
    Merck: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium

    M. Yang, None

    A. Smith, Cerexa, Inc: Employee, Salary

    Q. Zhao, Forest Laboratories: Employee, Salary

    X. Y. Huang, Forest Laboratories: Employee and Shareholder, Salary

    T. M. File Jr., Forest: Consultant and Scientific Advisor, Consulting fee

    Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 2nd with the exception of research findings presented at the IDWeek press conferences.