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FDA REVIEWING SEPSIS TERMINOLOGY FOR DRAFT "POINTS TO CONSIDER" DOCUMENT

Executive Summary

FDA is reviewing sepsis terminology for the draft "Points to Consider" document for sepsis trials, Anti-Infective Drugs Division Medical Reviewer Linda Sherman, MD, told the Anti- Infective Drugs Advisory Committee Sept. 24. "We are trying not to invent new terms," Sherman said. The advisory committee meeting was held to discuss the "Points to Consider" document on the development of clinical endpoints for sepsis drug trials (see following story). The Center for Drug Evaluation and Research is considering now, more "descriptive" terminology based on definitions of sepsis and related terms developed by a consensus group of physicians and published in American Chest Physicians' Critical Care Medicine in February 1992, Sherman reported. CDER's present terminology includes "bacteremia," an identified infection with at least one positive blood culture, and "septicemia and bacterial septicemia," an infection with at least two positive blood cultures. Sherman said those terms would be replaced by "sepsis" for "patients with infection, [systemic inflammatory response syndrome], positive blood cultures, and no organ dysfunction." The term "bacteremic sepsis," Sherman added, would "be a more descriptive term for sepsis patients listed above." Lastly, "severe sepsis/septic shock" would describe "patients with infection, SIRS and evidence of shock, perfusion abnormalities and/or end organ dysfunction," Sherman said. Sherman explained that the only difference from the consensus group's definitions is that FDA "suggests the use of 'bacteremic sepsis' to describe sepsis with organ dysfunction." The consensus group recommends "severe sepsis" to identify that condition. FDA's draft "Points to Consider" states that sepsis/bacteremic sepsis clinical trials should "include two adequate and well- controlled trials with a primary efficacy endpoint of survival [and] a secondary efficacy endpoint of negative blood cultures." Sherman stated that the inclusion criteria should consist of "men and women with evidence of SIRS and positive blood cultures." Patients would be required to have "no shock or perfusion abnormalities," she added. For septic shock/severe sepsis, Sherman stated that the "Points to Consider" document calls for "two adequate and well- controlled trials with a primary efficacy endpoint of mortality." The inclusion criteria, Sherman continued, is "men and women with SIRS, objective infection, shock, organ dysfunction [or] perfusion abnormalities."
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