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SAN DIEGO, CA— As presented at IDWeek 2012, the importance of clinical response at Day 4 in relation to hospital length of stay was demonstrated in two randomized controlled Phase 3 trials of patients who received ceftaroline fosamil and ceftriaxone for community-acquired pneumonia.
Earlier clinical endpoints to evaluate the efficacy of antimicrobial treatments have become an important assessment for trials in patients with community-acquired pneumonia. Ceftaroline fosamil is approved with FDA-defined clinical response at Day 4 (based on clinical stability and symptom improvement). In the FDA’s exploratory analysis, a 9.3% (95% CI: -1.35, 19.91) difference in clinical response was noted at Day 4 between ceftaroline fosamil-treated patients and ceftriaxone-treated patients (69.3% vs. 60%, respectively).
Using data from the FOCUS 1 and FOCUS 2 clinical trials, Thomas M. File, MD, of Northeast Ohio Medical University, Rootstown, OH, conducted an analysis of hospital length of stay among adult patients with community acquired pneumonia who achieved /did not achieve clinical response at Day 4.
Information on hospital admission, discharge dates, discharge status, and time in various inpatient units (e.g., intensive care unit, step-down unit, general medical/surgical, other) was collected from hospital summary forms. Data was collected from patients in four countries: Spain, Germany, Poland, and the U.S. Patient length of stay data were stratified by treatment, pathogen, country, PORT risk class, and between the cohorts achieving/not achieving clinical response at Day 4.
Of 320 subjects who met the inclusion criteria for length of stay analyses, 165 received ceftaroline fosamil and 155 received ceftriaxone. For patients infected with a typical pathogen, mean length of stay was 11.8 days for ceftaroline fosamil-treated patients and 12.6 days for ceftriaxone-treated patients.
The team further concluded that when comparing cohorts based on early response, mean length of stay was 11.2 days (95% CI 10.4–12) for patients achieving clinical response at Day 4; mean length of stay was 14 days (95% CI 12.3–15.7) for patients achieving vs. not achieving a clinical response at Day 4.
