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Volumn 16, Issue 1, 2012, Pages

A placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of single and multiple intravenous infusions of AZD9773 in patients with severe sepsis and septic shock

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CYTOFAB; DROTRECOGIN; INTERLEUKIN 6; PLACEBO; PROCALCITONIN; TUMOR NECROSIS FACTOR ALPHA; IMMUNOGLOBULIN F(AB) FRAGMENT;

EID: 84863404346     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc11203     Document Type: Article
Times cited : (23)

References (27)
  • 1
    • 34247338128 scopus 로고    scopus 로고
    • Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003
    • 10.1097/01.CCM.0000261890.41311.E9, 17414736
    • Dombrovskiy VY, Martin AA, Sunderram J, Paz HL. Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med 2007, 35:1244-1250. 10.1097/01.CCM.0000261890.41311.E9, 17414736.
    • (2007) Crit Care Med , vol.35 , pp. 1244-1250
    • Dombrovskiy, V.Y.1    Martin, A.A.2    Sunderram, J.3    Paz, H.L.4
  • 3
    • 33745205321 scopus 로고    scopus 로고
    • Treatment options for severe sepsis and septic shock
    • 10.1586/14787210.4.3.395, 16771617
    • Sharma VK, Dellinger RP. Treatment options for severe sepsis and septic shock. Expert Rev Anti Infect Ther 2006, 4:395-403. 10.1586/14787210.4.3.395, 16771617.
    • (2006) Expert Rev Anti Infect Ther , vol.4 , pp. 395-403
    • Sharma, V.K.1    Dellinger, R.P.2
  • 4
    • 0022508582 scopus 로고
    • Tumor necrosis factor/cachectin interacts with endothelial cell receptors to induce release of interleukin 1
    • 10.1084/jem.163.6.1363, 2188127, 3011946
    • Nawroth PP, Bank I, Handley D, Cassimeris J, Chess L, Stern D. Tumor necrosis factor/cachectin interacts with endothelial cell receptors to induce release of interleukin 1. J Exp Med 1986, 163:1363-1375. 10.1084/jem.163.6.1363, 2188127, 3011946.
    • (1986) J Exp Med , vol.163 , pp. 1363-1375
    • Nawroth, P.P.1    Bank, I.2    Handley, D.3    Cassimeris, J.4    Chess, L.5    Stern, D.6
  • 5
    • 0026351204 scopus 로고
    • The role of tumor necrosis factor in sepsis
    • 10.1016/0090-1229(92)90036-N, 1370262
    • Spooner CE, Markowitz NP, Saravolatz LD. The role of tumor necrosis factor in sepsis. Clin Immunol Immunopathol 1992, 62:S11-S17. 10.1016/0090-1229(92)90036-N, 1370262.
    • (1992) Clin Immunol Immunopathol , vol.62
    • Spooner, C.E.1    Markowitz, N.P.2    Saravolatz, L.D.3
  • 6
    • 0032997973 scopus 로고    scopus 로고
    • Cytokines and anticytokines in the pathogenesis of sepsis
    • 10.1016/S0891-5520(05)70083-0, 10340175
    • van der Poll T, van Deventer SJ. Cytokines and anticytokines in the pathogenesis of sepsis. Infect Dis Clin North Am 1999, 13:413-426. 10.1016/S0891-5520(05)70083-0, 10340175.
    • (1999) Infect Dis Clin North Am , vol.13 , pp. 413-426
    • van der Poll, T.1    van Deventer, S.J.2
  • 7
    • 0000912790 scopus 로고
    • Time course of cytokine levels in sepsis
    • Thijs LG, Hack CE. Time course of cytokine levels in sepsis. Intensive Care Med 1995, 21(Suppl 2):S258-S263.
    • (1995) Intensive Care Med , vol.21 , Issue.SUPPL. 2
    • Thijs, L.G.1    Hack, C.E.2
  • 8
    • 78650568172 scopus 로고    scopus 로고
    • Immunomodulation in sepsis: state of the art and future perspective
    • 10.2217/imt.10.82, 21174562
    • Antonopoulou A, Giamarellos-Bourboulis EJ. Immunomodulation in sepsis: state of the art and future perspective. Immunotherapy 2011, 3:117-128. 10.2217/imt.10.82, 21174562.
    • (2011) Immunotherapy , vol.3 , pp. 117-128
    • Antonopoulou, A.1    Giamarellos-Bourboulis, E.J.2
  • 9
    • 80053957554 scopus 로고    scopus 로고
    • The evolving experience with therapeutic TNF inhibition in sepsis: considering the potential influence of risk of death
    • 10.1517/13543784.2011.623125, 21961576
    • Qiu P, Cui X, Barochia A, Li Y, Natanson C, Eichacker PQ. The evolving experience with therapeutic TNF inhibition in sepsis: considering the potential influence of risk of death. Expert Opin Investig Drugs 2011, 20:1555-1564. 10.1517/13543784.2011.623125, 21961576.
    • (2011) Expert Opin Investig Drugs , vol.20 , pp. 1555-1564
    • Qiu, P.1    Cui, X.2    Barochia, A.3    Li, Y.4    Natanson, C.5    Eichacker, P.Q.6
  • 12
    • 0022495253 scopus 로고
    • Kinetics of the Fab fragments of digoxin antibodies and of bound digoxin in patients with severe digoxin intoxication
    • 10.1007/BF00542410, 3758140
    • Schaumann W, Kaufmann B, Neubert P, Smolarz A. Kinetics of the Fab fragments of digoxin antibodies and of bound digoxin in patients with severe digoxin intoxication. Eur J Clin Pharmacol 1986, 30:527-533. 10.1007/BF00542410, 3758140.
    • (1986) Eur J Clin Pharmacol , vol.30 , pp. 527-533
    • Schaumann, W.1    Kaufmann, B.2    Neubert, P.3    Smolarz, A.4
  • 13
    • 33747502519 scopus 로고    scopus 로고
    • Safety and efficacy of affinity-purified, anti-tumor necrosis factor-alpha, ovine fab for injection (CytoFab) in severe sepsis
    • 10.1097/01.CCM.0000230385.82679.34, 16810105
    • Rice TW, Wheeler AP, Morris PE, Paz HL, Russell JA, Edens TR, Bernard GR. Safety and efficacy of affinity-purified, anti-tumor necrosis factor-alpha, ovine fab for injection (CytoFab) in severe sepsis. Crit Care Med 2006, 34:2271-2281. 10.1097/01.CCM.0000230385.82679.34, 16810105.
    • (2006) Crit Care Med , vol.34 , pp. 2271-2281
    • Rice, T.W.1    Wheeler, A.P.2    Morris, P.E.3    Paz, H.L.4    Russell, J.A.5    Edens, T.R.6    Bernard, G.R.7
  • 15
    • 84863395875 scopus 로고    scopus 로고
    • Preclinical pharmacodynamics and safety profiling of AZD9773: a novel anti-TNF-α polyclonal immune ovine Fab similar to D-CytoFab
    • (P262)
    • Newham P, Yates JWT, Das S, Kemp J, Ceuppens P, Brennan F, Knight R, Growcott J. Preclinical pharmacodynamics and safety profiling of AZD9773: a novel anti-TNF-α polyclonal immune ovine Fab similar to D-CytoFab. Crit Care Med 2011, 15(Suppl 1):S93. (P262).
    • (2011) Crit Care Med , vol.15 , Issue.SUPPL. 1
    • Newham, P.1    Yates, J.W.T.2    Das, S.3    Kemp, J.4    Ceuppens, P.5    Brennan, F.6    Knight, R.7    Growcott, J.8
  • 16
    • 84863417024 scopus 로고    scopus 로고
    • Quantikine®. Human TNF-α Immunoassay. For the quantitative determination of human tumor necrosis factor alpha (TNF-alpha) concentrations in cell culture supernates, serum, and plasma
    • R&D Systems Europe
    • R&D Systems Europe Quantikine®. Human TNF-α Immunoassay. For the quantitative determination of human tumor necrosis factor alpha (TNF-alpha) concentrations in cell culture supernates, serum, and plasma. 2011, R&D Systems Europe., http://www.rndsystems.com/pdf/dta00c.pdf
    • (2011)
  • 17
    • 84863400177 scopus 로고    scopus 로고
    • Quantikine® ELISA. Human IL-6 Immunoassay. For the quantitative determination of human interleukin 6 (IL-6) concentrations in cell culture supernates, serum, and plasma
    • R&D Systems Europe
    • R&D Systems Europe Quantikine® ELISA. Human IL-6 Immunoassay. For the quantitative determination of human interleukin 6 (IL-6) concentrations in cell culture supernates, serum, and plasma. 2011, R&D Systems Europe., http://www.rndsystems.com/pdf/d6050.pdf
    • (2011)
  • 18
    • 84863417026 scopus 로고    scopus 로고
    • Brahms Diagnostic. Procalcitonin assays. 2011
    • Brahms Diagnostic. Procalcitonin assays. 2011. , http://www.procalcitonin.com/default.aspx?tree = _0
  • 19
    • 0030015661 scopus 로고    scopus 로고
    • The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine
    • 10.1007/BF01709751, 8844239
    • Vincent JL, Moreno R, Takala J, Willatts S, de Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996, 22:707-710. 10.1007/BF01709751, 8844239.
    • (1996) Intensive Care Med , vol.22 , pp. 707-710
    • Vincent, J.L.1    Moreno, R.2    Takala, J.3    Willatts, S.4    de Mendonça, A.5    Bruining, H.6    Reinhart, C.K.7    Suter, P.M.8    Thijs, L.G.9
  • 20
    • 60549104490 scopus 로고    scopus 로고
    • Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
    • European Medicines Agency
    • European Medicines Agency Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. 2007, European Medicines Agency., http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf
    • (2007)
  • 23
    • 84863417025 scopus 로고    scopus 로고
    • Population PK/PD modelling AZD9773 in patients with severe sepsis. 20th meeting of the Population Approach Group in Europe
    • abst 2147
    • Yates JW, Das S, Mainwaring G, Kemp J. Population PK/PD modelling AZD9773 in patients with severe sepsis. 20th meeting of the Population Approach Group in Europe. Athens, Greece 2011, abst 2147.
    • (2011) Athens, Greece
    • Yates, J.W.1    Das, S.2    Mainwaring, G.3    Kemp, J.4
  • 24
    • 84863411368 scopus 로고    scopus 로고
    • AZD9773, a novel anti-tumor necrosis factor-a immune Fab in development for severe sepsis and septic shock: analyses of complex formation and binding sites with TNF-α
    • (abst 183)
    • Newham P, Snow M, Eckersley S, Davies G, Abbott M. AZD9773, a novel anti-tumor necrosis factor-a immune Fab in development for severe sepsis and septic shock: analyses of complex formation and binding sites with TNF-α. Crit Care Med 2011, 39(Suppl 12):45. (abst 183).
    • (2011) Crit Care Med , vol.39 , Issue.SUPPL. 12 , pp. 45
    • Newham, P.1    Snow, M.2    Eckersley, S.3    Davies, G.4    Abbott, M.5
  • 25
    • 17644378667 scopus 로고    scopus 로고
    • Immunogenicity of engineered antibodies
    • 10.1016/j.ymeth.2005.01.001, 15848070
    • Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005, 36:3-10. 10.1016/j.ymeth.2005.01.001, 15848070.
    • (2005) Methods , vol.36 , pp. 3-10
    • Hwang, W.Y.1    Foote, J.2
  • 26
    • 84863417029 scopus 로고    scopus 로고
    • CroFab (Crotalidae Polyvalent Immune Fab) Prescribing Information
    • BTG International Inc
    • BTG International Inc CroFab (Crotalidae Polyvalent Immune Fab) Prescribing Information. 2010, BTG International Inc., http://www.crofab.com/viewpdf.do?documentId=1
    • (2010)
  • 27
    • 84863397683 scopus 로고    scopus 로고
    • Digibind (Digoxin Immune Fab) Summary of Product Characteristics
    • GlaxoSmithKline UK
    • GlaxoSmithKline UK Digibind (Digoxin Immune Fab) Summary of Product Characteristics. 2010, GlaxoSmithKline UK., http://www.medicines.org.uk/EMC/medicine/12476/SPC/Digibind/
    • (2010)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.