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
A randomized, blinded, multicenter trial was conducted to compare fluconazole (800 mg per day) plus placebo with fluconazole plus amphotericin B (AmB) deoxycholate (0.7 mg/kg per day, with the placebo/AmB component given only for the first 5-6 days) as therapy for candidemia due to species other tha...
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| Vydáno v: | Clinical infectious diseases Ročník 36; číslo 10; s. 1221 |
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| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
United States
15.05.2003
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| Témata: | |
| ISSN: | 1537-6591, 1537-6591 |
| On-line přístup: | Zjistit podrobnosti o přístupu |
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| Abstract | A randomized, blinded, multicenter trial was conducted to compare fluconazole (800 mg per day) plus placebo with fluconazole plus amphotericin B (AmB) deoxycholate (0.7 mg/kg per day, with the placebo/AmB component given only for the first 5-6 days) as therapy for candidemia due to species other than Candida krusei in adults without neutropenia. A total of 219 patients met criteria for a modified intent-to-treat analysis. The groups were similar except that those who were treated with fluconazole plus placebo had a higher mean (+/- standard error) Acute Physiology and Chronic Health Evaluation II score (16.8+/-0.6 vs. 15.0+/-0.7; P=.039). Success rates on study day 30 by Kaplan-Meier time-to-failure analysis were 57% for fluconazole plus placebo and 69% for fluconazole plus AmB (P=.08). Overall success rates were 56% (60 of 107 patients) and 69% (77 of 112 patients; P=.043), respectively; the bloodstream infection failed to clear in 17% and 6% of subjects, respectively (P=.02). In nonneutropenic subjects, the combination of fluconazole plus AmB was not antagonistic compared with fluconazole alone, and the combination trended toward improved success and more-rapid clearance from the bloodstream. |
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| AbstractList | A randomized, blinded, multicenter trial was conducted to compare fluconazole (800 mg per day) plus placebo with fluconazole plus amphotericin B (AmB) deoxycholate (0.7 mg/kg per day, with the placebo/AmB component given only for the first 5-6 days) as therapy for candidemia due to species other than Candida krusei in adults without neutropenia. A total of 219 patients met criteria for a modified intent-to-treat analysis. The groups were similar except that those who were treated with fluconazole plus placebo had a higher mean (+/- standard error) Acute Physiology and Chronic Health Evaluation II score (16.8+/-0.6 vs. 15.0+/-0.7; P=.039). Success rates on study day 30 by Kaplan-Meier time-to-failure analysis were 57% for fluconazole plus placebo and 69% for fluconazole plus AmB (P=.08). Overall success rates were 56% (60 of 107 patients) and 69% (77 of 112 patients; P=.043), respectively; the bloodstream infection failed to clear in 17% and 6% of subjects, respectively (P=.02). In nonneutropenic subjects, the combination of fluconazole plus AmB was not antagonistic compared with fluconazole alone, and the combination trended toward improved success and more-rapid clearance from the bloodstream.A randomized, blinded, multicenter trial was conducted to compare fluconazole (800 mg per day) plus placebo with fluconazole plus amphotericin B (AmB) deoxycholate (0.7 mg/kg per day, with the placebo/AmB component given only for the first 5-6 days) as therapy for candidemia due to species other than Candida krusei in adults without neutropenia. A total of 219 patients met criteria for a modified intent-to-treat analysis. The groups were similar except that those who were treated with fluconazole plus placebo had a higher mean (+/- standard error) Acute Physiology and Chronic Health Evaluation II score (16.8+/-0.6 vs. 15.0+/-0.7; P=.039). Success rates on study day 30 by Kaplan-Meier time-to-failure analysis were 57% for fluconazole plus placebo and 69% for fluconazole plus AmB (P=.08). Overall success rates were 56% (60 of 107 patients) and 69% (77 of 112 patients; P=.043), respectively; the bloodstream infection failed to clear in 17% and 6% of subjects, respectively (P=.02). In nonneutropenic subjects, the combination of fluconazole plus AmB was not antagonistic compared with fluconazole alone, and the combination trended toward improved success and more-rapid clearance from the bloodstream. A randomized, blinded, multicenter trial was conducted to compare fluconazole (800 mg per day) plus placebo with fluconazole plus amphotericin B (AmB) deoxycholate (0.7 mg/kg per day, with the placebo/AmB component given only for the first 5-6 days) as therapy for candidemia due to species other than Candida krusei in adults without neutropenia. A total of 219 patients met criteria for a modified intent-to-treat analysis. The groups were similar except that those who were treated with fluconazole plus placebo had a higher mean (+/- standard error) Acute Physiology and Chronic Health Evaluation II score (16.8+/-0.6 vs. 15.0+/-0.7; P=.039). Success rates on study day 30 by Kaplan-Meier time-to-failure analysis were 57% for fluconazole plus placebo and 69% for fluconazole plus AmB (P=.08). Overall success rates were 56% (60 of 107 patients) and 69% (77 of 112 patients; P=.043), respectively; the bloodstream infection failed to clear in 17% and 6% of subjects, respectively (P=.02). In nonneutropenic subjects, the combination of fluconazole plus AmB was not antagonistic compared with fluconazole alone, and the combination trended toward improved success and more-rapid clearance from the bloodstream. |
| Author | Stein, David K Cleary, John D Brass, Corstiaan Bradsher, Robert W Hilton, Eileen Goodman, Jesse Lee, Jeannette Edwards, John E Schuster, Mindy Rex, John H Rubin, Robert H Washburn, Ronald G Zervos, Marcus Panzer, Helene Horowitz, Harold W Mautner, Linda Chu, Teng-Chiao McKinsey, David Lutz, Jon Babinchak, Timothy Sobel, Jack Kett, Daniel H Hyslop, Newton E Chapman, Stanley W Hadley, Susan Danziger, Larry Rosenstein, Rebecca B Pappas, Peter G Goldman, Mitchell Karchmer, Adolf W Simmons, Bryan Scheld, W Michael Booth, Jenia Vazquez, Jose A Cohen, David M |
| Author_xml | – sequence: 1 givenname: John H surname: Rex fullname: Rex, John H email: john@rexweb.org organization: Division of Infectious Diseases, University of Texas Medical School, Houston, TX 77030, USA. john@rexweb.org – sequence: 2 givenname: Peter G surname: Pappas fullname: Pappas, Peter G – sequence: 3 givenname: Adolf W surname: Karchmer fullname: Karchmer, Adolf W – sequence: 4 givenname: Jack surname: Sobel fullname: Sobel, Jack – sequence: 5 givenname: John E surname: Edwards fullname: Edwards, John E – sequence: 6 givenname: Susan surname: Hadley fullname: Hadley, Susan – sequence: 7 givenname: Corstiaan surname: Brass fullname: Brass, Corstiaan – sequence: 8 givenname: Jose A surname: Vazquez fullname: Vazquez, Jose A – sequence: 9 givenname: Stanley W surname: Chapman fullname: Chapman, Stanley W – sequence: 10 givenname: Harold W surname: Horowitz fullname: Horowitz, Harold W – sequence: 11 givenname: Marcus surname: Zervos fullname: Zervos, Marcus – sequence: 12 givenname: David surname: McKinsey fullname: McKinsey, David – sequence: 13 givenname: Jeannette surname: Lee fullname: Lee, Jeannette – sequence: 14 givenname: Timothy surname: Babinchak fullname: Babinchak, Timothy – sequence: 15 givenname: Robert W surname: Bradsher fullname: Bradsher, Robert W – sequence: 16 givenname: John D surname: Cleary fullname: Cleary, John D – sequence: 17 givenname: David M surname: Cohen fullname: Cohen, David M – sequence: 18 givenname: Larry surname: Danziger fullname: Danziger, Larry – sequence: 19 givenname: Mitchell surname: Goldman fullname: Goldman, Mitchell – sequence: 20 givenname: Jesse surname: Goodman fullname: Goodman, Jesse – sequence: 21 givenname: Eileen surname: Hilton fullname: Hilton, Eileen – sequence: 22 givenname: Newton E surname: Hyslop fullname: Hyslop, Newton E – sequence: 23 givenname: Daniel H surname: Kett fullname: Kett, Daniel H – sequence: 24 givenname: Jon surname: Lutz fullname: Lutz, Jon – sequence: 25 givenname: Robert H surname: Rubin fullname: Rubin, Robert H – sequence: 26 givenname: W Michael surname: Scheld fullname: Scheld, W Michael – sequence: 27 givenname: Mindy surname: Schuster fullname: Schuster, Mindy – sequence: 28 givenname: Bryan surname: Simmons fullname: Simmons, Bryan – sequence: 29 givenname: David K surname: Stein fullname: Stein, David K – sequence: 30 givenname: Ronald G surname: Washburn fullname: Washburn, Ronald G – sequence: 31 givenname: Linda surname: Mautner fullname: Mautner, Linda – sequence: 32 givenname: Teng-Chiao surname: Chu fullname: Chu, Teng-Chiao – sequence: 33 givenname: Helene surname: Panzer fullname: Panzer, Helene – sequence: 34 givenname: Rebecca B surname: Rosenstein fullname: Rosenstein, Rebecca B – sequence: 35 givenname: Jenia surname: Booth fullname: Booth, Jenia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/12746765$$D View this record in MEDLINE/PubMed |
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| Title | 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 |
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