A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): Study protocol and design of a randomized controlled trial

Trials

Volumn 12, Issue , 2011, Pages

  Burns, Karen E A ^a,b   Chant, Clarence ^a,b   Smith, Orla ^a,b   Cuthbertson, Brian ^c   Fowler, Robert ^a,c   Cook, Deborah J ^d   Kruger, Peter ^e   Webb, Steve ^f   Alhashemi, Jamal ^g   Dominguez Cherit, Guillermo ^h   Zala, Carlos ⁱ   Rubenfeld, Gordon D ^c   Marshall, John C ^a,b  

^a UNIVERSITY OF TORONTO   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^d MCMASTER UNIVERSITY   (Canada)

^e PRINCESS ALEXANDRA HOSPITAL   (Australia)

^f ROYAL PERTH HOSPITAL   (Australia)

^g KING ABDULAZIZ UNIVERSITY   (Saudi Arabia)

^h INSTITUTO NACIONAL DE CIENCIAS MÉDICAS Y NUTRICIÓN SALVADOR ZUBIRÁN   (Mexico)

ⁱ Hospital Central de San Isidro   (Argentina)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; ROSUVASTATIN; ANTIINFLAMMATORY AGENT; ANTIVIRUS AGENT; FLUOROBENZENE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ADULT; ARTICLE; ARTIFICIAL VENTILATION; CANADA; CONTROLLED STUDY; CRITICALLY ILL PATIENT; HUMAN; HUMAN CELL; INFLUENZA A (H1N1); INFLUENZA VIRUS A H1N1; INFORMED CONSENT; INTENSIVE CARE; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MEDICAL RESEARCH; OUTCOME ASSESSMENT; PANDEMIC INFLUENZA; PHARMACIST; PHARMACY; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; STAFF; STUDY DESIGN; UNSPECIFIED SIDE EFFECT; VIRUS INFECTION; ACUTE DISEASE; ARGENTINA; AUSTRALIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; COOPERATION; CRITICAL ILLNESS; DRUG COMBINATION; FEASIBILITY STUDY; INFLUENZA; METHODOLOGY; MEXICO; MULTICENTER STUDY; NEW ZEALAND; PATHOGENICITY; PATIENT SELECTION; SAUDI ARABIA; TREATMENT OUTCOME; VIROLOGY;

ACUTE DISEASE; ANTI-INFLAMMATORY AGENTS; ANTIVIRAL AGENTS; ARGENTINA; AUSTRALIA; CANADA; COOPERATIVE BEHAVIOR; CRITICAL CARE; CRITICAL ILLNESS; DRUG THERAPY, COMBINATION; FEASIBILITY STUDIES; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; INFORMED CONSENT; MEXICO; NEW ZEALAND; PATIENT SELECTION; PILOT PROJECTS; PYRIMIDINES; RESEARCH DESIGN; RESPIRATION, ARTIFICIAL; SAUDI ARABIA; SULFONAMIDES; TREATMENT OUTCOME;

EID: 79952322009     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-70     Document Type: Article

References (40)

1. Cohen J, Enserink M. Swine flu. After delays, WHO agrees: the 2009 pandemic has begun. Science 2009, 324(5934):1496-1497. 10.1126/science.324_1496, 19541958.
2. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003, 289(2):179-186. 10.1001/jama.289.2.179, 12517228.
3. Johnson NP, Mueller J. Updating the accounts: global mortality of the 1918-1920 Spanish influenza pandemic. Bull Hist Med 2002, 76(1):105-115. 10.1353/bhm.2002.0022, 11875246.
4. Smith GJ, Bahl J, Vijaykrishna D, et al. Dating the emergence of pandemic influenza viruses. Proc Natl Acad Sci USA 2009, 106(28):11709-11712. 10.1073/pnas.0904991106, 2709671, 19597152.
5. Gambotto A, Barrett-Boyes SM, de Jong M, Neumann G, Kawaoka Y. Human infection with highly pathogenic H5N1 influenza virus. Lancet 2008, 371(9622):1464-1475. 10.1016/S0140-6736(08)60627-3, 18440429.
6. Perez-Padilla R, Rosa-Zamboni D, Ponce de LS, et al. Pneumonia and respiratory failure from swine-origin influenza A (H1N1) in Mexico. N Engl J Med 2009, 361(7):680-689. 10.1056/NEJMoa0904252, 19564631.
7. Kumar A, Zarychanski R, Pinto R, et al. Critically Ill Patients with Novel Swine Origin Influenza A/H1N1 in Canada. JAMA 2009, 302(17):1872-1879. 10.1001/jama.2009.1496, 19822627.
8. The ANZIC Influenza Investigators Critical Care Services and 2009 H1N1 Influenza in Australia and New Zealand. N Engl J Med 2009, The ANZIC Influenza Investigators.
9. Extracorporeal Membrane Oxygenation for 2009 Influenza A(H1N1) Acute Respiratory Distress Syndrome. JAMA 2009, 302(17):1888-95. 10.1001/jama.2009.1535, 19822628.
10. Pandemic (H1N1) 2009 briefing note 1 Viruses resistant to oseltamivir (Tamiflu) identified. Wkly Epidemiol Rec 2009, 84(29):299-399.
11. Oseltamivir-resistant 2009 pandemic influenza A (H1N1) virus infection in two summer campers receiving prophylaxis--North Carolina, 2009. MMWR Morb Mortal Wkly Rep 2009, 58(35):969-972.
12. Fedson DS. Meeting the challenge of influenza pandemic preparedness in developing countries. Emerg Infect Dis 2009, 15(3):365-371. 10.3201/eid1503.080857, 2681116, 19239746.
13. Fedson DS. Confronting an influenza pandemic with inexpensive generic agents: can it be done?. Lancet Infect Dis 2008, 8(9):571-576. 10.1016/S1473-3099(08)70070-7, 18420459.
14. Ooi EE, Chew JS, Loh JP, Chua RC. In vitro inhibition of human influenza A virus replication by chloroquine. Virol J 2006, 3:39. 10.1186/1743-422X-3-39, 1481635, 16729896.
15. Palamara AT, Nencioni L, Aquilano K, et al. Inhibition of influenza A virus replication by resveratrol. J Infect Dis 2005, 191(10):1719-1729. 10.1086/429694, 15838800.
16. Drago L, Nicola L, Ossola F, De VE. In vitro antiviral activity of resveratrol against respiratory viruses. J Chemother 2008, 20(3):393-394.
17. Enserink M. Infectious disease. Old drugs losing effectiveness against flu; could statins fill gap?. Science 2005, 309(5743):1976-1977. 10.1126/science.309.5743.1976a, 16179440.
18. Liappis AP, Kan VL, Rochester CG, Simon GL. The effect of statins on mortality in patients with bacteremia. Clin Infect Dis 2001, 33(8):1352-1357. 10.1086/323334, 11565076.
19. Thomsen RW, Riis A, Kornum JB, Christensen S, Johnsen SP, Sorensen HT. Preadmission use of statins and outcomes after hospitalization with pneumonia: population-based cohort study of 29,900 patients. Arch Intern Med 2008, 168(19):2081-2087. 10.1001/archinte.168.19.2081, 18955636.
20. Hackam DG, Mamdani M, Li P, Redelmeier DA. Statins and sepsis in patients with cardiovascular disease: a population-based cohort analysis. Lancet 2006, 367(9508):413-418. 10.1016/S0140-6736(06)68041-0, 16458766.
21. Chalmers JD, Singanayagam A, Murray MP, Hill AT. Prior statin use is associated with improved outcomes in community-acquired pneumonia. Am J Med 2008, 121(11):1002-1007. 10.1016/j.amjmed.2008.06.030, 18954848.
22. Tleyjeh IM, Kashour T, Hakim FA, et al. Statins for the prevention and treatment of infections: a systematic review and meta-analysis. Arch Intern Med 2009, 169(18):1658-1667. 10.1001/archinternmed.2009.286, 19822822.
23. Kopterides P, Falagas ME. Statins for sepsis: a critical and updated review. Clin Microbiol Infect 2009, 15(4):325-334. 10.1111/j.1469-0691.2009.02750.x, 19416304.
24. Falagas ME, Makris GC, Matthaiou DK, Rafailidis PI. Statins for infection and sepsis: a systematic review of the clinical evidence. J Antimicrob Chemother 2008, 61(4):774-785. 10.1093/jac/dkn019, 18263570.
25. Ponce J, de la Ossa NP, Hurtado O, et al. Simvastatin reduces the association of NMDA receptors to lipid rafts: a cholesterol-mediated effect in neuroprotection. Stroke 2008, 39(4):1269-1275. 10.1161/STROKEAHA.107.498923, 18323503.
26. Ghittoni R, Patrussi L, Pirozzi K, et al. Simvastatin inhibits T-cell activation by selectively impairing the function of Ras superfamily GTPases. FASEB J 2005, 19(6):605-607.
27. Yasuda H, Yuen PS, Hu X, Zhou H, Star RA. Simvastatin improves sepsis-induced mortality and acute kidney injury via renal vascular effects. Kidney Int 2006, 69(9):1535-1542. 10.1038/sj.ki.5000300, 2377392, 16557230.
28. Shyamsundar M, McKeown ST, O'Kane CM, et al. Simvastatin decreases lipopolysaccharide-induced pulmonary inflammation in healthy volunteers. Am J Respir Crit Care Med 2009, 179(12):1107-1114. 10.1164/rccm.200810-1584OC, 2695496, 19324974.
29. Liu Z, Guo Z, Wang G, et al. Evaluation of the efficacy and safety of a statin/caffeine combination against H5N1, H3N2 and H1N1 virus infection in BALB/c mice. Eur J Pharm Sci 2009, 38(3):215-223. 10.1016/j.ejps.2009.07.004, 19616097.
30. Frost FJ, Petersen H, Tollestrup K, Skipper B. Influenza and COPD mortality protection as pleiotropic, dose-dependent effects of statins. Chest 2007, 131(4):1006-1012. 10.1378/chest.06-1997, 17426203.
31. Vandermeer M, Thomas A, Kamimoto L, et al. Role of statins in preventing death among patients hospitalized with lab-confirmed influenza infections. Infectious Diseases Society of America 2009 Meeting; October 30, 2009; Philadelphia, PA Abstract 706.
32. Schmidt H, Hennen R, Keller A, et al. Association of statin therapy and increased survival in patients with multiple organ dysfunction syndrome. Intensive Care Med 2006, 32(8):1248-1251. 10.1007/s00134-006-0246-y, 16788803.
33. Kor DJ, Iscimen R, Yilmaz M, Brown MJ, Brown DR, Gajic O. Statin administration did not influence the progression of lung injury or associated organ failures in a cohort of patients with acute lung injury. Intensive Care Med 2009, 35(6):1039-1046. 10.1007/s00134-009-1421-8, 19183945.
34. McTaggart F, Buckett L, Davidson R, et al. Preclinical and clinical pharmacology of rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol 2001, 87(suppl):28B-32B. 10.1016/S0002-9149(01)01454-0, 11256847.
35. Crestor Product Monograph. 2010, AstraZeneca Inc., Mississauga, Ontario Canada, Last Revised: April 28, 2010. Last accessed October 26, 2010., http://www.astrazeneca.ca/documents/ProductPortfolio/CRESTOR_PM_en.pdf
36. Cook DJ, Blythe D, Rischbieth A, et al. Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers' experiences, beliefs, and practices. Crit Care Med 2008, 36(7):2100-2105. 10.1097/CCM.0b013e31817c00b0, 18552686.
37. Scripture CD, Pieper JA. Clinical pharmacokinetics of fluvastatin. Clin Pharmacokinet 2001, 40(4):263-281. 10.2165/00003088-200140040-00003, 11368292.
38. Ercole A, Taylor BL, Rhodes A, Menon DK. Modelling the impact of an influenza A/H1N1 pandemic on critical care demand from early pathogenicity data: the case for sentinel reporting. Anaesthesia 2009, 64(9):937-941. 10.1111/j.1365-2044.2009.06070.x, 19645759.
39. Cook D, Burns K, Finfer S, et al. Clinical research ethics for critically ill patients during the H1N1 pandemic. Crit Care Med 2009,
40. Levy MM, Baylor MS, Bernard GR, et al. Clinical issues and research in respiratory failure from severe acute respiratory syndrome. Am J Respir Crit Care Med 2005, 171(5):518-526. 10.1164/rccm.200405-621WS, 15591472.