Talactoferrin in Severe Sepsis: Results from the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial

Critical Care Medicine

Volumn 43, Issue 9, 2015, Pages 1832-1838

  Vincent, Jean Louis ^a   Marshall, John C ^b   Dellinger, R Phillip ^c   Simonson, Steven G ^d   Guntupalli, Kalpalatha ^e   Levy, Mitchell M ^f   Singer, Mervyn ^g   Malik, Rajesh ^h  

^a ERASME HOSPITAL   (Belgium)

^b UNIVERSITY OF TORONTO   (Canada)

^c Rowan University ^*  (United States)

^d Discovery Laboratories   (United States)

^e BAYLOR COLLEGE OF MEDICINE   (United States)

^f BROWN UNIVERSITY   (United States)

^g UNIVERSITY COLLEGE LONDON   (United Kingdom)

^h AGENNIX INC   (United States)

Author keywords

Gut associated lymphoid tissue; lactoferrin; sepsis; septic shock

Indexed keywords

PLACEBO; TALACTOFERRIN; ANTIINFECTIVE AGENT; LACTOFERRIN;

ADULT; ANTIMICROBIAL THERAPY; ARTICLE; ARTIFICIAL VENTILATION; CONTROLLED STUDY; DRUG SAFETY; FEMALE; HEART ARREST; HUMAN; INTENSIVE CARE UNIT; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; PHARMACEUTICAL CARE; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SEPSIS; SEPTIC SHOCK; SEVERE SEPSIS; TREATMENT DURATION; AGED; APACHE; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; MIDDLE AGED; SHOCK, SEPTIC; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTI-INFECTIVE AGENTS; APACHE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LACTOFERRIN; MALE; MIDDLE AGED; SEPSIS; SHOCK, SEPTIC;

EID: 84946125295     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0000000000001090     Document Type: Article

References (23)

1. Kaukonen KM, Bailey M, Suzuki S, et al: Mortality relat to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA 2014; 311:1308-1316
2. Vincent JL, Sakr Y, Sprung CL, et al; Sepsis Occurrence in Acutely Ill Patients Investigators: Sepsis in European intensive care units: Results of the SOAP study. Crit Care M 2006; 34:344-353
3. Dellinger RP, Levy MM, Rhodes A, et al; Surviving Sepsis Campaign Guidelines Committee including The Piatric Subgroup: Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock, 2012. Intensive Care M 2013; 39:165-228
4. Sun XL, Baker HM, Shewry SC, et al: Structure of recombinant human lactoferrin express in Aspergillus awamori. Acta Crystallogr D Biol Crystallogr 1999; 55:403-407
5. Manzoni P, Rinaldi M, Cattani S, et al; Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology: Bovine lactoferrin supplementation for prevention of lateonset sepsis in very low-birth-weight neonates: A randomiz trial. JAMA 2009; 302:1421-1428
6. Levay PF, Viljoen M: Lactoferrin: A general review. Haematologica 1995; 80:252-267
7. Legrand D, Elass E, Carpentier M, et al: Interactions of lactoferrin with cells involv in immune function. Biochem Cell Biol 2006; 84:282-290
8. de la Rosa G, Yang D, Tewary P et al: Lactoferrin acts as an alarmin to promote the recruitment and activation of APCs and antigen-specific immune responses. J Immunol 2008; 180:6868-6876
9. Spadaro M, Caorsi C, Ceruti P, et al: Lactoferrin, a major defense protein of innate immunity, is a novel maturation factor for human dendritic cells. FASEB J 2008; 22:2747-2757
10. Troost FJ, Saris WH, Brummer RJ: Recombinant human lactoferrin ingestion attenuates indomethacin-induc enteropathy in vivo in healthy volunteers. Eur J Clin Nutr 2003; 57:1579-1585
11. de L, Hipolito RB, Hwang FF, et al: Lactoferrin protects neonatal rats from gut-relat systemic infection. Am J Physiol Gastrointest Liver Physiol 2001; 281:G1140-G1150
12. Guntupalli K, Dean N, Morris PE, et al; TLF LF-0801 Investigator Group: A phase 2 randomiz, double-blind, placebo-controll study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care M 2013; 41:706-716
13. American College of Chest Physicians-Society of Critical Care Micine: Consensus Conference: Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care M 1992; 20:864-874
14. Knaus WA, Draper EA, Wagner DP, et al: APACHE II: A severity of disease classification system. Crit Care M 1985; 13:818-829
15. Vincent JL, Moreno R, Takala J, et al: The SOFA (Sepsis-relat Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Relat Problems of the European Society of Intensive Care Micine. Intensive Care M 1996; 22:707-710
16. Ramalingam S, Crawford J, Chang A, et al; FORTIS-M Study Investigators: Talactoferrin alfa versus placebo in patients with refractory advanc non-small-cell lung cancer (FORTIS-M trial). Ann Oncol 2013; 24:2875-2880
17. Parikh PM, Vaid A, Advani SH, et al: Randomiz, double-blind, placebo-controll phase II study of single-agent oral talactoferrin in patients with locally advanc or metastatic non-small-cell lung cancer that progress after chemotherapy. J Clin Oncol 2011; 29:4129-4136
18. Ranieri VM, Thompson BT, Barie PS, et al; PROWESS-SHOCK Study Group: Drotrecogin alfa (activat) in adults with septic shock. N Engl J M 2012; 366:2055-2064
19. Annane D, Siami S, Jaber S, et al; CRISTAL Investigators: Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: The CRISTAL randomiz trial. JAMA 2013; 310:1809-1817
20. Perner A, Haase N, Guttormsen AB, et al; 6S Trial Group; Scandinavian Critical Care Trials Group: Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J M 2012; 367:124-134
21. Finfer S, Chittock DR, Su SY et al: Intensive versus conventional glucose control in critically ill patients. N Engl J M 2009; 360:1283-1297
22. Bernard GR, Vincent JL, Laterre PF, et al; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group: Efficacy and safety of recombinant human activat protein C for severe sepsis. N Engl J M 2001; 344:699-709
23. Vincent JL, Van Nuffelen M: Septic shock: New pharmacotherapy options or better trial design? Expert Opin Pharmacother 2013; 14:561-570