Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the In
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ORIGINAL RESEARCH
Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam Miguel Sa´nchez-Garcı´a . Jennifer Hammond . Jean Li Yan . Michal Kantecki . Wajeeha Ansari . Matthew Dryden Received: December 31, 2019 Ó Pfizer Inc. 2020
ABSTRACT Aim: Exploratory analyses evaluated patient characteristics and outcomes among patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU). Methods: Adults with cSSTI (surface area C 75 cm2) and evidence of systemic inflammation and/or underlying comorbidities were randomized 2:1 to intravenous ceftaroline fosamil Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare. 12006168. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40121020-00297-3) contains supplementary material, which is available to authorized users. M. Sa´nchez-Garcı´a (&) Hospital Clı´nico San Carlos, Calle del Prof Martı´n Lagos, Madrid, Spain e-mail: [email protected] J. Hammond Pfizer, Collegeville, PA, USA J. L. Yan W. Ansari Pfizer, New York, NY, USA M. Kantecki Pfizer, Paris, France M. Dryden Royal Hampshire County Hospital, Winchester, UK
(600 mg every 8 h [q8h]) or vancomycin (15 mg/kg every 12 h) plus aztreonam (1 g q8h) for 5–14 days. Clinical response and ICU length of stay (LOS) within first hospitalization were evaluated in the modified intent-to-treat (MITT) and clinically evaluable (CE) populations; a Cox proportional hazards model identified factors associated with increased hospital LOS. Results: Overall, 42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n = 32; vancomycin plus aztreonam, n = 10) prior to, or at start of, study treatment. Baseline differences between the ICU and non-ICU populations were indicative of more severe disease in ICU patients; within this subset, there were also some notable imbalances between treatment groups. Clinical cure rates at test-ofcure (ceftaroline fosamil vs. vancomycin plus aztreonam) were generally similar in the nonICU and ICU subsets (MITT population 79% vs. 79% and 69% vs. 90.0%, respectively; CE population 87% vs. 85% and 80% vs. 89%, respectively). Median ICU LOS was 8 vs. 13 days, respectively. ICU admission was a risk factor predicting increased hospital LOS (P \ 0.001). Conclusions: Clinical outcomes for patients admitted to the ICU were generally similar to non-ICU patients, despite more severe baseline disease, with shorter median treatment duration in the ceftaroline fosamil group. ICU admission was associated with longer hospital LOS. Given the small sample size and
Infect Dis Ther
unbalanced patient and disease characteristics within the ICU subgroup, differences between treatment groups should be interpreted with caution. Trial registration: C
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