A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation

Jesse L. Goodman, Daniel Weisdorf, Drew J. Winston, Winston G. ho, Ronald A. Greenfield, Pranatharthi H. Chandrasekar, Barry Fox, Herbert Kaizer, Richard K. Shadduck, Thomas C. Shea, Patrick Stiff, David J. Friedman, William G. Powderly, Jeffrey L. Silber, Harold Horowitz, Alan Lichtin, Steven N. Wolff, Kenneth F. Mangan, Samuel M. Silver, Gene Gilbert & 1 others Donald Buell

Research output: Contribution to journalArticle

1009 Citations (Scopus)

Abstract

Superficial and systemic fungal infections are a major problem among severely immunocompromised patients who undergo bone marrow transplantation. We performed a doubleblind, randomized, multicenter trial in which patients receiving bone marrow transplants were randomly assigned to receive placebo or fluconazole (400 mg daily). Fluconazole or placebo was administered prophylactically from the start of the conditioning regimen until the neutrophil count returned to 1000 per microliter, toxicity was suspected, or a systemic fungal infection was suspected or proved. By the end of the treatment period, 67.2 percent of the 177 patients assigned to placebo had a positive fungal culture of specimens from any site, as compared with 29.6 percent of the 179 patients assigned to fluconazole. Among these, superficial infections were diagnosed in 33.3 percent of the patients receiving placebo and in 8.4 percent of the patients receiving fluconazole (P<0.001). Systemic fungal infections occurred in 28 patients who received placebo as compared with 5 who received fluconazole (15.8 percent vs. 2.8 percent, P<0.001). Fluconazole prevented infection with all strains of candida except Candida krusei. Fluconazole was well tolerated, although patients who received it had a higher mean increase in alanine aminotransferase levels than patients who received placebo. Although there was no significant difference in overall mortality between the groups, fewer deaths were ascribed to acute systemic fungal infections in the group receiving fluconazole than in the group receiving placebo (1 of 179 vs. 10 of 177, P<0.001). Prophylactic administration of fluconazole to recipients of bone marrow transplants reduces the incidence of both systemic and superficial fungal infections. (N Engl J Med 1992;326:845–51.).

Original languageEnglish (US)
Pages (from-to)845-851
Number of pages7
JournalNew England Journal of Medicine
Volume326
Issue number13
DOIs
StatePublished - Mar 26 1992

Fingerprint

Mycoses
Fluconazole
Bone Marrow Transplantation
Placebos
Candida
Bone Marrow
Transplants
Immunocompromised Host
Infection
Alanine Transaminase
Multicenter Studies
Neutrophils
Mortality
Incidence

Cite this

Goodman, J. L., Weisdorf, D., Winston, D. J., ho, W. G., Greenfield, R. A., Chandrasekar, P. H., ... Buell, D. (1992). A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. New England Journal of Medicine, 326(13), 845-851. https://doi.org/10.1056/NEJM199203263261301

A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. / Goodman, Jesse L.; Weisdorf, Daniel; Winston, Drew J.; ho, Winston G.; Greenfield, Ronald A.; Chandrasekar, Pranatharthi H.; Fox, Barry; Kaizer, Herbert; Shadduck, Richard K.; Shea, Thomas C.; Stiff, Patrick; Friedman, David J.; Powderly, William G.; Silber, Jeffrey L.; Horowitz, Harold; Lichtin, Alan; Wolff, Steven N.; Mangan, Kenneth F.; Silver, Samuel M.; Gilbert, Gene; Buell, Donald.

In: New England Journal of Medicine, Vol. 326, No. 13, 26.03.1992, p. 845-851.

Research output: Contribution to journalArticle

Goodman, JL, Weisdorf, D, Winston, DJ, ho, WG, Greenfield, RA, Chandrasekar, PH, Fox, B, Kaizer, H, Shadduck, RK, Shea, TC, Stiff, P, Friedman, DJ, Powderly, WG, Silber, JL, Horowitz, H, Lichtin, A, Wolff, SN, Mangan, KF, Silver, SM, Gilbert, G & Buell, D 1992, 'A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation', New England Journal of Medicine, vol. 326, no. 13, pp. 845-851. https://doi.org/10.1056/NEJM199203263261301
Goodman, Jesse L. ; Weisdorf, Daniel ; Winston, Drew J. ; ho, Winston G. ; Greenfield, Ronald A. ; Chandrasekar, Pranatharthi H. ; Fox, Barry ; Kaizer, Herbert ; Shadduck, Richard K. ; Shea, Thomas C. ; Stiff, Patrick ; Friedman, David J. ; Powderly, William G. ; Silber, Jeffrey L. ; Horowitz, Harold ; Lichtin, Alan ; Wolff, Steven N. ; Mangan, Kenneth F. ; Silver, Samuel M. ; Gilbert, Gene ; Buell, Donald. / A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. In: New England Journal of Medicine. 1992 ; Vol. 326, No. 13. pp. 845-851.
@article{ce027155512240ac963a142a3be8d0e1,
title = "A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation",
abstract = "Superficial and systemic fungal infections are a major problem among severely immunocompromised patients who undergo bone marrow transplantation. We performed a doubleblind, randomized, multicenter trial in which patients receiving bone marrow transplants were randomly assigned to receive placebo or fluconazole (400 mg daily). Fluconazole or placebo was administered prophylactically from the start of the conditioning regimen until the neutrophil count returned to 1000 per microliter, toxicity was suspected, or a systemic fungal infection was suspected or proved. By the end of the treatment period, 67.2 percent of the 177 patients assigned to placebo had a positive fungal culture of specimens from any site, as compared with 29.6 percent of the 179 patients assigned to fluconazole. Among these, superficial infections were diagnosed in 33.3 percent of the patients receiving placebo and in 8.4 percent of the patients receiving fluconazole (P<0.001). Systemic fungal infections occurred in 28 patients who received placebo as compared with 5 who received fluconazole (15.8 percent vs. 2.8 percent, P<0.001). Fluconazole prevented infection with all strains of candida except Candida krusei. Fluconazole was well tolerated, although patients who received it had a higher mean increase in alanine aminotransferase levels than patients who received placebo. Although there was no significant difference in overall mortality between the groups, fewer deaths were ascribed to acute systemic fungal infections in the group receiving fluconazole than in the group receiving placebo (1 of 179 vs. 10 of 177, P<0.001). Prophylactic administration of fluconazole to recipients of bone marrow transplants reduces the incidence of both systemic and superficial fungal infections. (N Engl J Med 1992;326:845–51.).",
author = "Goodman, {Jesse L.} and Daniel Weisdorf and Winston, {Drew J.} and ho, {Winston G.} and Greenfield, {Ronald A.} and Chandrasekar, {Pranatharthi H.} and Barry Fox and Herbert Kaizer and Shadduck, {Richard K.} and Shea, {Thomas C.} and Patrick Stiff and Friedman, {David J.} and Powderly, {William G.} and Silber, {Jeffrey L.} and Harold Horowitz and Alan Lichtin and Wolff, {Steven N.} and Mangan, {Kenneth F.} and Silver, {Samuel M.} and Gene Gilbert and Donald Buell",
year = "1992",
month = "3",
day = "26",
doi = "10.1056/NEJM199203263261301",
language = "English (US)",
volume = "326",
pages = "845--851",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "13",

}

TY - JOUR

T1 - A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation

AU - Goodman, Jesse L.

AU - Weisdorf, Daniel

AU - Winston, Drew J.

AU - ho, Winston G.

AU - Greenfield, Ronald A.

AU - Chandrasekar, Pranatharthi H.

AU - Fox, Barry

AU - Kaizer, Herbert

AU - Shadduck, Richard K.

AU - Shea, Thomas C.

AU - Stiff, Patrick

AU - Friedman, David J.

AU - Powderly, William G.

AU - Silber, Jeffrey L.

AU - Horowitz, Harold

AU - Lichtin, Alan

AU - Wolff, Steven N.

AU - Mangan, Kenneth F.

AU - Silver, Samuel M.

AU - Gilbert, Gene

AU - Buell, Donald

PY - 1992/3/26

Y1 - 1992/3/26

N2 - Superficial and systemic fungal infections are a major problem among severely immunocompromised patients who undergo bone marrow transplantation. We performed a doubleblind, randomized, multicenter trial in which patients receiving bone marrow transplants were randomly assigned to receive placebo or fluconazole (400 mg daily). Fluconazole or placebo was administered prophylactically from the start of the conditioning regimen until the neutrophil count returned to 1000 per microliter, toxicity was suspected, or a systemic fungal infection was suspected or proved. By the end of the treatment period, 67.2 percent of the 177 patients assigned to placebo had a positive fungal culture of specimens from any site, as compared with 29.6 percent of the 179 patients assigned to fluconazole. Among these, superficial infections were diagnosed in 33.3 percent of the patients receiving placebo and in 8.4 percent of the patients receiving fluconazole (P<0.001). Systemic fungal infections occurred in 28 patients who received placebo as compared with 5 who received fluconazole (15.8 percent vs. 2.8 percent, P<0.001). Fluconazole prevented infection with all strains of candida except Candida krusei. Fluconazole was well tolerated, although patients who received it had a higher mean increase in alanine aminotransferase levels than patients who received placebo. Although there was no significant difference in overall mortality between the groups, fewer deaths were ascribed to acute systemic fungal infections in the group receiving fluconazole than in the group receiving placebo (1 of 179 vs. 10 of 177, P<0.001). Prophylactic administration of fluconazole to recipients of bone marrow transplants reduces the incidence of both systemic and superficial fungal infections. (N Engl J Med 1992;326:845–51.).

AB - Superficial and systemic fungal infections are a major problem among severely immunocompromised patients who undergo bone marrow transplantation. We performed a doubleblind, randomized, multicenter trial in which patients receiving bone marrow transplants were randomly assigned to receive placebo or fluconazole (400 mg daily). Fluconazole or placebo was administered prophylactically from the start of the conditioning regimen until the neutrophil count returned to 1000 per microliter, toxicity was suspected, or a systemic fungal infection was suspected or proved. By the end of the treatment period, 67.2 percent of the 177 patients assigned to placebo had a positive fungal culture of specimens from any site, as compared with 29.6 percent of the 179 patients assigned to fluconazole. Among these, superficial infections were diagnosed in 33.3 percent of the patients receiving placebo and in 8.4 percent of the patients receiving fluconazole (P<0.001). Systemic fungal infections occurred in 28 patients who received placebo as compared with 5 who received fluconazole (15.8 percent vs. 2.8 percent, P<0.001). Fluconazole prevented infection with all strains of candida except Candida krusei. Fluconazole was well tolerated, although patients who received it had a higher mean increase in alanine aminotransferase levels than patients who received placebo. Although there was no significant difference in overall mortality between the groups, fewer deaths were ascribed to acute systemic fungal infections in the group receiving fluconazole than in the group receiving placebo (1 of 179 vs. 10 of 177, P<0.001). Prophylactic administration of fluconazole to recipients of bone marrow transplants reduces the incidence of both systemic and superficial fungal infections. (N Engl J Med 1992;326:845–51.).

UR - http://www.scopus.com/inward/record.url?scp=0026597735&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0026597735&partnerID=8YFLogxK

U2 - 10.1056/NEJM199203263261301

DO - 10.1056/NEJM199203263261301

M3 - Article

VL - 326

SP - 845

EP - 851

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 13

ER -