Ceftarolin Fosamil in Patients with Complicated Skin and Soft Tissue Infections Admitted to ICU

Ceftaroline Fosamil in the Treatment of cSSTI

Ceftaroline fosamil is a beta-lactam antibiotic that shows in vitro activity against methicillin-resistant strains of Staphylococcus aureus. In the phase III clinical trial program CANVAS, it demonstrated efficacy at a dose of 600 mg in a one-hour i.v. infusion administered every 12 hours in patients with cSSTI.

The COVERS study subsequently demonstrated its efficacy and safety at a higher dosage of 600 mg in a 2-hour i.v. infusion every 8 hours in patients with cSSTI and comorbidities, showing non-inferiority compared to vancomycin + aztreonam in terms of the primary endpoint, which was the proportion of patients with clinical recovery at the recovery evaluation visit.

Evaluated Population and Treatment Course

In June 2020, the results of a research analysis of the COVERS study focused on patients admitted to the ICU were published. The COVERS study included adult patients with cSSTI with an affected area ≥ 75 cm², documented systemic inflammation, or comorbidities. They were randomized in a 2:1 ratio to receive high-dose ceftaroline fosamil or vancomycin (15 mg every 12 hours) + aztreonam (1 g every 8 hours) for 5–14 days.

In addition to the proportion of patients with clinical recovery, the length of hospitalization in the ICU was also evaluated.

Results

Before or during the evaluated treatment, 42 of the 761 randomized patients were admitted to the ICU (32 received ceftaroline fosamil and 10 received vancomycin + aztreonam). These patients, as expected, had more severe infections.

For the clinically evaluable population, clinical recovery was achieved in the ICU-admitted population in 87% of those with ceftaroline fosamil and in 89% of patients with vancomycin + aztreonam. This proportion was similar to patients not admitted to the ICU: 87% vs. 85%.

The length of stay in the ICU was 8 days for patients with ceftaroline fosamil and 13 days for those with vancomycin + aztreonam. A shorter ICU stay with ceftaroline fosamil treatment was observed across all primary cSSTI diagnoses.

Conclusion

Although adult patients with cSSTI and comorbidities admitted to the ICU had a more severe disease course than those not admitted, the clinical outcomes achieved with high-dose ceftaroline fosamil were similar. Compared to vancomycin + aztreonam, treatment with ceftaroline fosamil was associated with a shorter ICU stay.

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Source: Sánchez-García M., Hammond J., Yan J. L. et al. 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. Infect Dis Ther 2020 Sep; 9 (3): 609−623, doi: 10.1007/s40121-020-00297-3.