Abstract
It is widely acknowledged that sepsis causes substantial morbidity and mortality among the critically ill [1]. Over the years, clinical trials of new therapies for sepsis have failed to find a successful treatment [2–7], yet industry and academia continue to search for the magic bullet cure.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsPreview
Unable to display preview. Download preview PDF.
References
Fisher CJ, Agosti JM, Opal SM, et al(1996) Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. N Engl J Med 334: 1697–1702
Bone RC, Fisher CJ Jr, Clemmer TP, Slotman GJ, Metz CA, Balk RA (1987) A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock. N Engl J Med 317: 653–658
Calandra T, Glauser MP, Schellekens J, Verhoef J (1988) Treatment of Gram-negative septic shock with human IgG antibody to Escherichia coli J5: A prospective, double-blind, randomized trial. J Infect Dis 158: 312–319
Greenman RL, Schein RM, Martin MA, et al(1991) A controlled clinical trial of E5 murine monoclonal IgM antibody to endotoxin in the treatment of Gram-negative sepsis. The XOMA Sepsis Study Group. JAMA 266: 1097–1102
Ziegler EJ, Fisher CJ Jr, Sprung CL, et al(1991) Treatment of Gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin. A randomized, double-blind, placebo-controlled trial. The HA-1A Sepsis Study Group. N Engl J Med 324: 429–436
Knaus WA, Harrel FE, Fisher CJ, et al(1993) The clinical evaluation of new drugs for sepsis: A prospective study design based on survival analysis. JAMA 270: 1233–1241
Fisher CJ, Slotman GJ, Opal SM, et al(1994) Initial evaluation of human recombinant interleukin-1 receptor antagonist in the treatment of sepsis syndrome: A randomized, open-label, placebo-controlled multicenter trial. Crit Care Med 22: 12–21
Van Dervort AL, Danner RL (1994) Antiendotoxin approaches to septic shock therapy (editorial). Crit Care Med 22: 539–540
Bone RC, Fisher CJ, and the Methylprednisolone Severe Sepsis Study Group (1987) Early methylprednisolone treatment for septic syndrome and the adult respiratory distress syndrome. Chest 92: 1032–1036
Weg JG, Balk RA, Tharratt S, et al(1994) Safety and potential efficacy of an aerosolized surfactant in human sepsis-induced adult respiratory distress syndrome. JAMA 272: 1433–1437
Luce JM (1994) Introduction of new technology into critical care practice: A history of HA-1A human monoclonal antibody against endotoxin. Grit Care Med 21: 1233–1241
Sprung CL, Finch RG, Thijs LG, Glauser MP (1996) International sepsis trial ( INTERSEPT ): Role and impact of a Clinical Evaluation Committee. Crit Care Med 24: 1441–1447
Sibbald WJ, Vincent JL (1995) Round table conference on clinical trials for the treatment of sepsis. Crit Care Med 23: 394–399
Doig GS, Rochon J (1995) Statistical considerations for the design of the optimal clinical trial. In: Vincent JL, Sibbald WJ (eds) Update in Intensive Care and Emergency Medicine Vol 19: Clinical Trials for the Treatment of Sepsis. Springer-Verlag, New York, pp 345–353
Spilker B, Cramer JA (1992) A frame of reference for patient recruitment issues. In: Spilker B, Cramer JA (eds) Patient Recruitment in Clinical Trials. Raven Press, New York, pp 3–23
Meinert CL (1986) Single versus multicenter trials. In: Meinert CL, Tonascia S (eds) Clinical Trials: Design, Conduct and Analysis. Oxford University Press, New York, pp 23–29
Pocock SJ (1983) The size of a clinical trial: Multicenter trials. In: Pocock SJ (ed) Clinical trials: A practical approach. John Wiley and Sons, Chichester, pp 123–142
Members of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference Committee (1992) Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 20: 864–874
Sibbald WJ, Doig GS, Inman KJ (1995) Sepsis, SIRS and infection. Intensive Care Med 21: 299–301
Seip A, Connolly S, Laupacis A, et al(1990) Systems of logging exclusions in multicenter clinical trials. Society for Clinical Trials Annual Meeting, Toronto (Abst)
Meinert CL (1986) Essential design features of a control clinical trial. In: Meinert CL, Tonascia S (eds) Clinical Trials: Design, Conduct and Analysis. Oxford University Press, New York, pp 65–68
Kreger BE, Craven DE, McCabe WR (1980) Gram-negative bacteremia. Am J Med 68: 344–355
Thijs LG (1995) Fluid therapy in septic shock. In: Vincent JL, Sibbald WJ (eds) Update in Intensive Care and Emergency Medicine Vol 19: Clinical Trials for the Treatment of Sepsis. Springer-Verlag, New York, pp 167–190
Cook DJ, Guyett GH, Laupacis A, Sackett DL (1992) Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest 102 (Suppl): 3055–3115
Cohen J, Carlet J, for the INTERSEPT Study Group (1996) INTERSEPT: An international, multicenter, placebo-controlled trial of monoclonal antibody to human tumor necrosis factor-a in patients with sepsis. Grit Care Med 24: 1431–1440
Bone RC, Balk RA, Fein AM, et al(1995) A second large controlled clinical study of E5, a monoclonal antibody to endotoxin: Results of a prospective, multicenter, randomized, controlled trial. Crit Care Med 23: 994–1006
Schedel I, Dreikhausen U, Nentwig B, et al(1991) Treatment of Gram-negative septic shock with an immunoglobulin preparation: A prospective, randomized clinical trial. Grit Care Med 19: 1104–1113
Dhainaut JA, Tenaillon A, Le Tulzo Y, et al(1994) Platelet activating factor receptor antagonist BN 52021 in the treatment of severe sepsis: A randomized, double-blind, placebo-controlled, multicenter clinical trial. Crit Care Med 22: 1720–1728
Fisher CJ, Agosti JM, Opal SM, et al(1996) Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. N Engl J Med 334: 1697–1702
Greenberg RN, Wilson KM, Kunz Ay, et al(1992) Observations using antiendotoxin antibody (E5) as adjuvant therapy in humans with suspected, serious, Gram-negative sepsis. Crit Care Med 20: 730–735
Abraham E,Wunderink R, Silverman H, et al(1995) Efficacy and safety of monoclonal antibody to human tumor necrosis factor a in patients with sepsis syndrome. A randomized, controlled, double-blind, multicenter clinical trial. JAMA 273: 934–941
McCloskey RV, Straube RC, Sanders C, et al(1994) Treatment of septic shock with human monoclonal antibody HA-1A. Ann Intern Med 121: 1–5
Fisher CJ, Dhainaut JA, Opal SM, et al(1994) Recombinant human interleukin-1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. JAMA 271: 1836–1843
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1997 Springer-Verlag Berlin Heidelberg
About this paper
Cite this paper
Foster, D.M., Doig, G.S. (1997). Clinical Trials for the Evaluation of Sepsis Therapies. In: Vincent, JL. (eds) Yearbook of Intensive Care and Emergency Medicine 1997. Yearbook of Intensive Care and Emergency Medicine, vol 1997. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-13450-4_15
Download citation
DOI: https://doi.org/10.1007/978-3-662-13450-4_15
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-662-13452-8
Online ISBN: 978-3-662-13450-4
eBook Packages: Springer Book Archive