Empirical fluconazole versus placebo for intensive care unit patients: A randomized trial

Annals of Internal Medicine

Volumn 149, Issue 2, 2008, Pages 83-90

  Schuster, Mindy G ^a   Edwards Jr , John E ^b   Sobel, Jack D ^c   Darouiche, Rabih O ^d   Karchmer, Adolf W ^e   Hadley, Susan ^f   Slotman, Gus ^g   Panzer, Helene ^h   Biswas, Pinaki ^h   Rex, John H ⁱ  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UCLA MEDICAL CENTER   (United States)

^c WAYNE STATE UNIVERSITY   (United States)

^d MICHAEL E DEBAKEY VETERANS AFFAIRS MEDICAL CENTER   (United States)

^e BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^f TUFTS MEDICAL CENTER   (United States)

^g Pfizer ^*  (United States)

^h PFIZER INC   (United States)

ⁱ ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; FLUCONAZOLE; PLACEBO; ANTIFUNGAL AGENT;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; APACHE; ARTICLE; CANDIDA; CENTRAL VENOUS CATHETER; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROL GROUP; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CRITICALLY ILL PATIENT; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG WITHDRAWAL; ENLARGED ABDOMEN; FEMALE; FEVER; HEART ARREST; HIGH RISK PATIENT; HUMAN; HYPOTENSION; INTENSIVE CARE UNIT; INVASIVE CANDIDIASIS; LIVER EXAMINATION; LIVER FUNCTION; MAJOR CLINICAL STUDY; MALE; NEUTROPHIL COUNT; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY DISTRESS SYNDROME; RESPIRATORY TRACT DISEASE; RISK FACTOR; SEPSIS; SIDE EFFECT; SKIN DISEASE; SKIN ULCER; THROMBOCYTE COUNT; UNITED STATES; URINARY TRACT INFECTION; AGED; CANDIDIASIS; CROSS INFECTION; FOLLOW UP; FUNGEMIA; INTENSIVE CARE; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY;

ADULT; AGED; ANTIFUNGAL AGENTS; CANDIDIASIS; CRITICAL CARE; CROSS INFECTION; DOUBLE-BLIND METHOD; FEMALE; FLUCONAZOLE; FOLLOW-UP STUDIES; FUNGEMIA; HUMANS; INTENSIVE CARE UNITS; MALE; MIDDLE AGED; RISK FACTORS;

EID: 47549089281     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-149-2-200807150-00004     Document Type: Article

References (27)

1. Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, et al. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995;274:639-44. [PMID: 7637145]
2. Macphail GL, Taylor GD, Buchanan-Chell M, Ross C, Wilson S, Kureishi A. Epidemiology, treatment and outcome of candidemia: a five-year review at three Canadian hospitals. Mycoses. 2002;45:141-5. [PMID: 12100528]
3. Blumberg HM, Jarvis WR, Soucie JM, Edwards JE, Patterson JE, Pfaller MA, et al. National Epidemiology of Mycoses Survey (NEMIS) Study Group. Risk factors for candidal bloodstream infections in surgical intensive care unit patients: the NEMIS prospective multicenter study. The National Epidemiology of Mycosis Survey. Clin Infect Dis. 2001;33:177-86. [PMID: 11418877]
4. Petri MG, König J, Moecke HP, Gramm HJ, Barkow H, Kujath P, et al. Epidemiology of invasive mycosis in ICU patients: a prospective multicenter study in 435 non-neutropenic patients. Paul-Ehrlich Society for Chemotherapy, Divisions of Mycology and Pneumonia Research. Intensive Care Med. 1997;23:317-25. [PMID: 9083235]
5. Wey SB, Mori M, Pfaller MA, Woolson RF, Wenzel RP. Hospital-acquired candidemia. The attributable mortality and excess length of stay. Arch Intern Med. 1988;148:2642-5. [PMID: 3196127]
6. Rentz AM, Halpern MT, Bowden R. The impact of candidemia on length of hospital stay, outcome, and overall cost of illness. Clin Infect Dis. 1998;27:781-8. [PMID: 9798034]
7. Nolla-Salas J, Sitges-Serra A, León-Gil C, Martínez- González J, León-Regidor MA, Ibáñez-Lucía P, et al. Candidemia in non-neutropenic critically ill patients: analysis of prognostic factors and assessment of systemic antifungal therapy. Study Group of Fungal Infection in the ICU. Intensive Care Med. 1997;23:23-30. [PMID: 9037636]
8. Zaoutis TE, Argon J, Chu J, Berlin JA, Walsh TJ, Feudtner C. The epidemiology and attributable outcomes of candidemia in adults and children hospitalized in the United States: a propensity analysis. Clin Infect Dis. 2005;41:1232-9. [PMID: 16206095]
9. Pittet D, Monod M, Suter PM, Frenk E, Auckenthaler R. Candida colonization and subsequent infections in critically ill surgical patients. Ann Surg. 1994;220:751-8. [PMID: 7986142]
10. Bross J, Talbot GH, Maislin G, Hurwitz S, Strom BL. Risk factors for nosocomial candidemia: a case-control study in adults without leukemia. Am J Med. 1989;87:614-20. [PMID: 2589396]
11. Berenguer J, Buck M, Witebsky F, Stock F, Pizzo PA, Walsh TJ. Lysiscentrifugation blood cultures in the detection of tissue-proven invasive candidiasis. Disseminated versus single-organ infection. Diagn Microbiol Infect Dis. 1993;17:103-9. [PMID: 8243032]
12. Eggimann P, Francioli P, Bille J, Schneider R, Wu MM, Chapuis G, et al. Fluconazole prophylaxis prevents intra-abdominal candidiasis in high-risk surgical patients. Crit Care Med. 1999;27:1066-72. [PMID: 10397206]
13. Ables AZ, Blumer NA, Valainis GT, Godenick MT, Kajdasz DK, Palesch YY. Fluconazole prophylaxis of severe Candida infection in trauma and postsurgical patients: a prospective, double-blind, randomized, placebo-controlled trial. Infect Dis Clin Pract. 2000;9:169-75.
14. Garbino J, Lew DP, Romand JA, Hugonnet S, Auckenthaler R, Pittet D. 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;28:1708-17. [PMID: 12447512]
15. Pelz RK, Hendrix CW, Swoboda SM, Diener-West M, Merz WG, Hammond J, et al. Double-blind placebo-controlled trial of fluconazole to prevent candidal infections in critically ill surgical patients. Ann Surg. 2001;233:542-8. [PMID: 11303137]
16. Wingard JR, Merz WG, Rinaldi MG, Johnson TR, Karp JE, Saral R. Increase in Candida krusei infection among patients with bone marrow transplantation and neutropenia treated prophylactically with fluconazole. N Engl J Med. 1991;325:1274-7. [PMID: 1669837]
17. Abi-Said D, Anaissie E, Uzun O, Raad I, Pinzcowski H, Vartivarian S. The epidemiology of hematogenous candidiasis caused by different Candida species. Clin Infect Dis. 1997;24:1122-8. [PMID: 9195068]
18. Garbino J, Romand J, Suter PM, Pittet D. Use of antibiotics in patients receiving intensive care. Clin Intensive Care. 1998;9:25-35.
19. Rex JH, Rinaldi MG, Pfaller MA. Resistance of Candida species to fluconazole. Antimicrob Agents Chemother. 1995;39:1-8. [PMID: 7695288]
20. Wingard JR, Merz WG, Rinaldi MG, Miller CB, Karp JE, Saral R. Association of Torulopsis glabrata infections with fluconazole prophylaxis in neutropenic bone marrow transplant patients. Antimicrob Agents Chemother. 1993;37:1847-9. [PMID: 8239594]
21. White MH. The contribution of fluconazole to the changing epidemiology of invasive candidal infections [Editorial]. Clin Infect Dis. 1997;24:1129-30. [PMID: 9195069]
22. Pizzo PA. Management of fever in patients with cancer and treatment-induced neutropenia. N Engl J Med. 1993;328:1323-32. [PMID: 8469254]
23. Hughes WT, Armstrong D, Bodey GP, Brown AE, Edwards JE, Feld R, et al. 1997 guidelines for the use of antimicrobial agents in neutropenic patients with unexplained fever. Infectious Diseases Society of America. Clin Infect Dis. 1997;25:551-73. [PMID: 9314442]
24. Golan Y, Wolf MP, Pauker SG, Wong JB, Hadley S. Empirical anti-Candida therapy among selected patients in the intensive care unit: a cost-effectiveness analysis. Ann Intern Med. 2005;143:857-69. [PMID: 16365467]
25. Rex JH, Bennett JE, Sugar AM, Pappas PG, van der Horst CM, Edwards JE, 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;331:1325-30. [PMID: 7935701]
26. Rex JH, Pappas PG, Karchmer AW, Sobel J, Edwards JE, Hadley S, et al. National Institute of Allergy and Infectious Diseases Mycoses Study Group. A randomized and blinded multicenter trial of high-dose fluconazole plus placebo versus fluconazole plus amphotericin B as therapy for candidemia and its consequences in nonneutropenic subjects. Clin Infect Dis. 2003;36:1221-8. [PMID: 12746765]
27. Cruciani M, de Lalla F, Mengoli C. Prophylaxis of Candida infections in adult trauma and surgical intensive care patients: a systematic review and meta-analysis. Intensive Care Med. 2005;31:1479-87. [PMID: 16172847]