Clinical Trials of Mediator-Targeted Therapy in Sepsis

  • J. C. Marshall
Conference paper


Over the past two decades, more than five dozen phase II and phase III randomized controlled trials have been undertaken, testing the hypothesis that modulation of the host inflammatory response can improve survival in sepsis. Despite a compelling pre-clinical rationale, and promising preliminary data, none of these have led to the licensing of new therapies. It has even been suggested that the recurring failure of well-designed clinical studies to demonstrate improved sur-vival for a variety of different therapeutic approaches should lead to a moratorium on clinical research, until the reasons for this failure are better understood [1]. Yet important insights can be gleaned from the body of work that has been performed to date. The b iolog ic concept remains v iable; the challenges involved in clin i c al investigation are formidable.


Septic Shock Acute Pancreatitis Severe Sepsis Sepsis Syndrome Negative Infection 
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© Springer-Verlag Italia 2000

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  • J. C. Marshall

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