Journal of Antimicrobial Chemotherapy, Vol 41, 95-102, Copyright © 1998 by The British Society for Antimicrobial Chemotherapy
RG Finch
The pathophysiology of sepsis has been studied intensively in recent years
and a variety of opportunities for therapeutic intervention have been
identified. A number of biological products including endotoxin antibodies,
cytokine inhibitors and receptor antagonists have been evaluated after the
failure of pharmacological doses of steroids to influence survival in
septic shock. Despite a number of large, international multi-centre
studies, the therapeutic promise of these various interventions remains
unfulfilled. These trials have largely been conducted in intensive care
units in a heterogeneous population of patients with various entry criteria
and end-points of response. While the clinical trial must remain the
standard for assessing safety and efficacy of new interventions there are
opportunities to improve on the design, execution and analysis of these
studies. Factors such as the appropriateness of antibiotic therapy, the
adequacy of medical and surgical management, and the issue of withdrawal or
withholding of life support are discussed in relation to these studies.
Furthermore the role of an independent scientific extramural review
committee is stressed, particularly in relation to the impact of
confounding events of an unforeseen nature. The potential for improving the
quality of the analyses of clinical trials of sepsis is illustrated by a
recently completed study of the efficacy of a murine monoclonal antibody to
human tumour necrosis factor-alpha.
ORIGINAL ARTICLES
Design of clinical trials in sepsis: problems and pitfalls
Department of Microbiology and Infectious Diseases, City Hospital, UK.
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