Issues in the design and interpretation of antifungal drug trials in the critically ill

Current Opinion in Infectious Diseases

Volumn 22, Issue 6, 2009, Pages 564-567

  Ostrosky Zeichner, Luis ^a  

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

Author keywords

Clinical trials; Critical care; Fungal infections

Indexed keywords

ANTIFUNGAL AGENT; CASPOFUNGIN; FLUCONAZOLE; PLACEBO;

ARTIFICIAL VENTILATION; CANDIDIASIS; CLINICAL TRIAL; CRITICALLY ILL PATIENT; DRUG DESIGN; HUMAN; INFECTION PREVENTION; INTENSIVE CARE; INTENSIVE CARE UNIT; INVASIVE CANDIDIASIS; MORBIDITY; MORTALITY; MYCOSIS; PATIENT SELECTION; PERITONITIS; REVIEW; TREATMENT RESPONSE;

ANTIFUNGAL AGENTS; ASPERGILLOSIS; CANDIDIASIS; CLINICAL TRIALS AS TOPIC; CRITICAL ILLNESS; HUMANS; PREMEDICATION; PREVENTIVE MEDICINE;

EID: 70350534560     PISSN: 09517375     EISSN: 14736527     Source Type: Journal    
DOI: 10.1097/QCO.0b013e328331fc5f     Document Type: Review

References (24)

1. Pfaller MA, Diekema DJ. Epidemiology of invasive candidiasis: a persistent public health problem. Clin Microbiol Rev 2007; 20:133-163.
2. Wisplinghoff H, Bischoff T, Tallent SM, et al. Nosocomial bloodstream infections in US hospitals: analysis of 24 179 cases from a prospective nationwide surveillance study. Clin Infect Dis 2004; 39:309-317.
3. Meersseman W, Van Wijngaerden E. Invasive aspergillosis in the ICU: an emerging disease. Intensive Care Med 2007; 33:1679-1681.
4. Falagas ME, Apostolou KE, Pappas VD. Attributable mortality of candidemia: a systematic review of matched cohort and case-control studies. Eur J Clin Microbiol Infect Dis 2006; 25:419-425.
5. Fridkin SK. Candidemia is costly: plain and simple. Clin Infect Dis 2005; 41:1240-1241.
6. Garey KW, Rege M, Pai MP, et al. Time to initiation of fluconazole therapy impacts mortality in patients with candidemia: a multiinstitutional study. Clin Infect Dis 2006; 43:25-31.
7. Eggimann P, Francioli P, Bille J, et al. Fluconazole prophylaxis prevents intra-abdominal candidiasis in high-risk surgical patients. Crit Care Med 1999; 27:1066-1072.
8. Pelz RK, Hendrix CW, Swoboda SM, et al. Double-blind placebo-controlled trial of fluconazole to prevent candidal infections in critically ill surgical patients. Ann Surg 2001; 233:542-548.
9. Garbino J, Lew DP, Romand JA, et al. Prevention of severe Candida infections in nonneutropenic, high-risk, critically ill patients: a randomized, double-blind, placebo-controlled trial in patients treated by selective digestive decontamination. Intensive Care Med 2002; 28:1708-1717.
10. Playford EG, Webster AC, Sorrell TC, et al. Antifungal agents for preventing fungal infections in nonneutropenic critically ill and surgical patients: systematic review and meta-analysis of randomized clinical trials. J Antimicrob Chemother 2006; 57:628-638.
11. Shorr AF, Chung K, Jackson WL, et al. Fluconazole prophylaxis in critically ill surgical patients: a meta-analysis. Crit Care Med 2005; 33:1928-1935.
12. Wenzel RP. Nosocomial candidemia: risk factors and attributable mortality. Clin Infect Dis 1995; 20:1531-1534.
13. Ostrosky-Zeichner L, Sable C, Sobel J, et al. Multicenter retrospective development and validation of a clinical prediction rule for nosocomial invasive candidiasis in the intensive care setting. Eur J Clin Microbiol Infect Dis 2007; 26:271-276
14. Ostrosky-Zeichner L, Pappas PG, Shoham S, et al. Improvement of a clinical prediction rule for clinical trials on prophylaxis for invasive candidiasis in the intensive care unit. Mycoses 2009
15. Pappas PG, Kauffman CA, Andes D, et al. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis 2009; 48:503-535.
16. Schuster MG, Edwards JE Jr, Sobel JD, et al. Empirical fluconazole versus placebo for intensive care unit patients: a randomized trial. Ann Intern Med 2008; 149:83-90.
17. Mohr JF, PaetznickV, Rodriguez J, et al.A Prospective pilot survey of B-glucan seropositivity and its relationship to invasive candidiasis in the surgical ICU. Abstract #M-168. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2005; Washington, D.C.; 2005.
18. Takesue Y, Kakehashi M, Ohge H, et al. Combined assessment of beta-D-glucan and degree of candida colonization before starting empiric therapy for candidiasis in surgical patients. World J Surg 2004; 28:625-630.
19. Akamatsu N, Sugawara Y, Kaneko J, et al. Preemptive treatment of fungal infection based on plasma (1 -> 3)beta-D-glucan levels after liver transplantation. Infection 2007; 35:346-351.
20. Mora-Duarte J, Betts R, Rotstein C, et al. Comparison of caspofungin and amphotericin B for invasive candidiasis. N Engl J Med 2002; 347:2020-2029.
21. RexJH, Bennett JE, Sugar AM, et al.A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute. N Engl J Med 1994; 331:1325-1330.
22. Reboli AC, Rotstein C, Pappas PG, et al. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med 2007; 356:2472-2482.
23. Pappas PG, Rotstein CM, Betts RF, et al. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis 2007; 45:883-893
24. Segal BH, Herbrecht R, Stevens DA, et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis 2008; 47:674-683.