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The clinical significance of the systemic inflammatory response in infected patients remains unclear. We examined risk factors for hospital mortality in 3,608 intensive care unit patients included in the European Sepsis Study. Patients were categorized as having infection without or with (i.e., sepsis) systemic inflammatory response, severe sepsis, and septic shock, on the first day of infection. Hospital mortality varied from 25 to 60% according to sepsis stage, but did not differ between the first two categories (hazard ratio, 0.94; p = 0.55), whereas there was a grading of severity from sepsis to severe sepsis (1.53, p < 10-4) and septic shock (2.64, p < 10-4). Within each stage, mortality was unaffected by the number of inflammatory response criteria. Prognostic factors identified by Cox regression included comorbid conditions, severity of acute illness and acute organ dysfunction, shock, nosocomial infection, and infection caused by aerobic gram-negative bacilli, enterobacteria, Staphylococcus aureus, and infection from a digestive or unknown source. We conclude that whereas the categorization of infection by the presence of organ dysfunction or shock has strong prognostic significance, infection and sepsis have similar outcomes, unaffected by the presence or number of inflammatory response criteria. Refinement of risk stratification of patients presenting with infection and no organ dysfunction is needed.