search
Back to results

Antifungal Use in Oncohematological Neutropenic Patients

Primary Purpose

Invader Fungal Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Antifungal drug. VORICONAZOL. (VFEND®)
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invader Fungal Infection focused on measuring Neutropenia, Antifungals

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult and pediatric patients (from 2 years old on) with diagnostic of hematologic malignancies or solid tumour.
  • Patients who will develop neutropenia (<500PN) post chemotherapy or post Bone Marrow Transplantation (BMT) that according to the center, they can receive empirical antifungal treatment of broad-spectrum.
  • Controlled patients with galactomannan in blood twice weekly.
  • Empirical antibacterial therapy of broad-spectrum, as possible the Pethema protocol that it is activated in this moment. Also it will be validated the monotherapy with carbapenemic or cephalosporin of fourth or third generation, or the biotherapy.
  • Inclusion of patient since the start of his chemotherapy or therapy of preparation.
  • If a bacterial infection is documented, it will be treated and controlled before to begin the empirical antifungal treatment.
  • Signed of informed consent.
  • Negative pregnancy test in fertile patients

Exclusion Criteria:

  • Use of antifungal prophylaxis with triazoles with activity against Aspergillus, or use of others systematics antifungal by previous Invader Fungal Infection or other reasons.
  • Use prophylactic of fluconazole to dose higher than 100 mg/day.
  • Allergy to azoles
  • To have a invader fungal infection at start of episode of neutropenia with fever.
  • High effect in the unity of insulation of Candida strong to fluconazole that to opinion of center it hasn´t appropriate to include in a protocol where it is considered the use of empirical fluconazole.
  • Neutropenias made by aplastic anemia or other faults of bone similar.
  • Inclusion previous in this study.
  • The patients will be excluded if they have settled by Aspergillus, C.krusei or C.gladiata in this episode of neutropenia, or in other and if they lack of the results of the cultures of vigilance in the present episode. If it presents positive result for any of those pathogens the empirical treatment will must be with a antifungal that it covers good (amphotericin, caspofungin or voriconazole) and not with fluconazole, then those patients will not follow this protocol.
  • To receive drugs, which aren´t indicated in patients in treatment with voriconazole and/or with fluconazole.
  • The patients will not be excluded if they receive antibacterial prophylaxis oral with quinolones, macrolides, etc., or stimulating factors G-CSF, GM-CSF or similar.
  • Cause of exclusion will be the fault of fulfilment of inclusion criteria. Above all the patients will be excluded if they:
  • have fault of twice weekly monitoring with galactomannan.
  • have a bacterial infection not very good treated and controlled before to can begin the empirical antifungal infection (according to definition previous)
  • have at final, a neutropenia of short stay that it has a risk important of Invader Fungal Infection. This data naturally will not know in the moment of include at patient in the study. It defines as neutropenia of short stay if it last out less of 5 days.

Sites / Locations

  • Hospital General de Jerez de la Frontera
  • Hospital Son Llatzer
  • Hospital Clínic
  • Hospital Virgen de las Nieves
  • Hospital General Universitario Gregorio Marañón, Madrid
  • Hospital Universitario de la Princesa
  • Hospital Universitario Ramón y Cajal, Madrid
  • Hospital Universitario Morales Meseguer, Murcia
  • Hospital Clínico Universitario de Salamanca
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario La Fe
  • Hospital Clínico Lozano Blesa

Outcomes

Primary Outcome Measures

Frequency of use of broad-spectrum antifungals in the episode of neutropenia.

Secondary Outcome Measures

To determine the safety and toxicity measure by:
Frequency of Invader Fungal Infection.
Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study.
Mortality
Development of nephrotoxicity
Use of galactomannan in this clinical context
Time of administration of empirical antifungal therapy of broad-spectrum.

Full Information

First Posted
October 11, 2006
Last Updated
September 17, 2009
Sponsor
PETHEMA Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00386802
Brief Title
Antifungal Use in Oncohematological Neutropenic Patients
Official Title
ANTIVORIFUNGOL:Strategy of Antifungal Use in Oncohematological Neutropenic Patients. Use of Voriconazole as Early Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PETHEMA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of neutropenia. Secondary purposes:To determine the safety and toxicity measure by: Frequency of Invader Fungal Infection. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. Mortality Development of nephrotoxicity Use of galactomannan in this clinical context Time of administration of empirical antifungal therapy of broad-spectrum.
Detailed Description
Clinical trial with a pharmaceutical speciality in the conditions of authorized use

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invader Fungal Infection
Keywords
Neutropenia, Antifungals

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Antifungal drug. VORICONAZOL. (VFEND®)
Intervention Description
I.V charge dose 6 mg/kg/12h (2 doses) Maintenance iv treatment 4 mg/kg/12h during 6 days, followed by oral treatment (200 mg/12h)
Primary Outcome Measure Information:
Title
Frequency of use of broad-spectrum antifungals in the episode of neutropenia.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To determine the safety and toxicity measure by:
Time Frame
1 year
Title
Frequency of Invader Fungal Infection.
Time Frame
2 years
Title
Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study.
Time Frame
2 years
Title
Mortality
Time Frame
2 years
Title
Development of nephrotoxicity
Time Frame
2 years
Title
Use of galactomannan in this clinical context
Time Frame
2 years
Title
Time of administration of empirical antifungal therapy of broad-spectrum.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult and pediatric patients (from 2 years old on) with diagnostic of hematologic malignancies or solid tumour. Patients who will develop neutropenia (<500PN) post chemotherapy or post Bone Marrow Transplantation (BMT) that according to the center, they can receive empirical antifungal treatment of broad-spectrum. Controlled patients with galactomannan in blood twice weekly. Empirical antibacterial therapy of broad-spectrum, as possible the Pethema protocol that it is activated in this moment. Also it will be validated the monotherapy with carbapenemic or cephalosporin of fourth or third generation, or the biotherapy. Inclusion of patient since the start of his chemotherapy or therapy of preparation. If a bacterial infection is documented, it will be treated and controlled before to begin the empirical antifungal treatment. Signed of informed consent. Negative pregnancy test in fertile patients Exclusion Criteria: Use of antifungal prophylaxis with triazoles with activity against Aspergillus, or use of others systematics antifungal by previous Invader Fungal Infection or other reasons. Use prophylactic of fluconazole to dose higher than 100 mg/day. Allergy to azoles To have a invader fungal infection at start of episode of neutropenia with fever. High effect in the unity of insulation of Candida strong to fluconazole that to opinion of center it hasn´t appropriate to include in a protocol where it is considered the use of empirical fluconazole. Neutropenias made by aplastic anemia or other faults of bone similar. Inclusion previous in this study. The patients will be excluded if they have settled by Aspergillus, C.krusei or C.gladiata in this episode of neutropenia, or in other and if they lack of the results of the cultures of vigilance in the present episode. If it presents positive result for any of those pathogens the empirical treatment will must be with a antifungal that it covers good (amphotericin, caspofungin or voriconazole) and not with fluconazole, then those patients will not follow this protocol. To receive drugs, which aren´t indicated in patients in treatment with voriconazole and/or with fluconazole. The patients will not be excluded if they receive antibacterial prophylaxis oral with quinolones, macrolides, etc., or stimulating factors G-CSF, GM-CSF or similar. Cause of exclusion will be the fault of fulfilment of inclusion criteria. Above all the patients will be excluded if they: have fault of twice weekly monitoring with galactomannan. have a bacterial infection not very good treated and controlled before to can begin the empirical antifungal infection (according to definition previous) have at final, a neutropenia of short stay that it has a risk important of Invader Fungal Infection. This data naturally will not know in the moment of include at patient in the study. It defines as neutropenia of short stay if it last out less of 5 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
de la Cámara Rafael, Dr
Organizational Affiliation
Hospital Universitario de la Princesa, Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
Mallorca
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón, Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal, Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Morales Meseguer, Murcia
City
Murcia
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
11918531
Citation
Kami M, Machida U, Okuzumi K, Matsumura T, Mori Si S, Hori A, Kashima T, Kanda Y, Takaue Y, Sakamaki H, Hirai H, Yoneyama A, Mutou Y. Effect of fluconazole prophylaxis on fungal blood cultures: an autopsy-based study involving 720 patients with haematological malignancy. Br J Haematol. 2002 Apr;117(1):40-6. doi: 10.1046/j.1365-2141.2002.03414.x.
Results Reference
background
PubMed Identifier
4913991
Citation
Young RC, Bennett JE, Vogel CL, Carbone PP, DeVita VT. Aspergillosis. The spectrum of the disease in 98 patients. Medicine (Baltimore). 1970 Mar;49(2):147-73. doi: 10.1097/00005792-197003000-00002. No abstract available.
Results Reference
background
PubMed Identifier
8842991
Citation
Groll AH, Shah PM, Mentzel C, Schneider M, Just-Nuebling G, Huebner K. Trends in the postmortem epidemiology of invasive fungal infections at a university hospital. J Infect. 1996 Jul;33(1):23-32. doi: 10.1016/s0163-4453(96)92700-0.
Results Reference
background
PubMed Identifier
7058815
Citation
Pizzo PA, Robichaud KJ, Gill FA, Witebsky FG. Empiric antibiotic and antifungal therapy for cancer patients with prolonged fever and granulocytopenia. Am J Med. 1982 Jan;72(1):101-11. doi: 10.1016/0002-9343(82)90594-0. No abstract available.
Results Reference
background
PubMed Identifier
2658574
Citation
Empiric antifungal therapy in febrile granulocytopenic patients. EORTC International Antimicrobial Therapy Cooperative Group. Am J Med. 1989 Jun;86(6 Pt 1):668-72. doi: 10.1016/0002-9343(89)90441-5.
Results Reference
background
PubMed Identifier
10585786
Citation
Wingard JR, Kubilis P, Lee L, Yee G, White M, Walshe L, Bowden R, Anaissie E, Hiemenz J, Lister J. Clinical significance of nephrotoxicity in patients treated with amphotericin B for suspected or proven aspergillosis. Clin Infect Dis. 1999 Dec;29(6):1402-7. doi: 10.1086/313498.
Results Reference
background
PubMed Identifier
11229835
Citation
Bates DW, Su L, Yu DT, Chertow GM, Seger DL, Gomes DR, Dasbach EJ, Platt R. Mortality and costs of acute renal failure associated with amphotericin B therapy. Clin Infect Dis. 2001 Mar 1;32(5):686-93. doi: 10.1086/319211. Epub 2001 Feb 21.
Results Reference
background
PubMed Identifier
12471588
Citation
Harbarth S, Burke JP, Lloyd JF, Evans RS, Pestotnik SL, Samore MH. Clinical and economic outcomes of conventional amphotericin B-associated nephrotoxicity. Clin Infect Dis. 2002 Dec 15;35(12):e120-7. doi: 10.1086/344468. Epub 2002 Dec 2.
Results Reference
background
PubMed Identifier
15459300
Citation
Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402. doi: 10.1056/NEJMoa040446.
Results Reference
background
PubMed Identifier
11807146
Citation
Walsh TJ, Pappas P, Winston DJ, Lazarus HM, Petersen F, Raffalli J, Yanovich S, Stiff P, Greenberg R, Donowitz G, Schuster M, Reboli A, Wingard J, Arndt C, Reinhardt J, Hadley S, Finberg R, Laverdiere M, Perfect J, Garber G, Fioritoni G, Anaissie E, Lee J; National Institute of Allergy and Infectious Diseases Mycoses Study Group. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med. 2002 Jan 24;346(4):225-34. doi: 10.1056/NEJM200201243460403. Erratum In: N Engl J Med. 2007 Feb 15;356(7):760.
Results Reference
background
PubMed Identifier
9870832
Citation
Malik IA, Moid I, Aziz Z, Khan S, Suleman M. A randomized comparison of fluconazole with amphotericin B as empiric anti-fungal agents in cancer patients with prolonged fever and neutropenia. Am J Med. 1998 Dec;105(6):478-83. doi: 10.1016/s0002-9343(98)00326-x.
Results Reference
background
PubMed Identifier
9081359
Citation
Viscoli C, Castagnola E, Van Lint MT, Moroni C, Garaventa A, Rossi MR, Fanci R, Menichetti F, Caselli D, Giacchino M, Congiu M. Fluconazole versus amphotericin B as empirical antifungal therapy of unexplained fever in granulocytopenic cancer patients: a pragmatic, multicentre, prospective and randomised clinical trial. Eur J Cancer. 1996 May;32A(5):814-20. doi: 10.1016/0959-8049(95)00619-2.
Results Reference
background
PubMed Identifier
11014720
Citation
Winston DJ, Hathorn JW, Schuster MG, Schiller GJ, Territo MC. A multicenter, randomized trial of fluconazole versus amphotericin B for empiric antifungal therapy of febrile neutropenic patients with cancer. Am J Med. 2000 Mar;108(4):282-9. doi: 10.1016/s0002-9343(99)00457-x.
Results Reference
background
PubMed Identifier
14717790
Citation
McLintock LA, Jordanides NE, Allan EK, Copland M, Stewart K, Parker A, Devaney M, Holyoake TL, Jones BL. The use of a risk group stratification in the management of invasive fungal infection: a prospective validation. Br J Haematol. 2004 Feb;124(3):403-4. doi: 10.1046/j.1365-2141.2003.04794.x. No abstract available.
Results Reference
background
PubMed Identifier
14987199
Citation
Wheat LJ. Rapid diagnosis of invasive aspergillosis by antigen detection. Transpl Infect Dis. 2003 Dec;5(4):158-66. doi: 10.1111/j.1399-3062.2003.00031.x.
Results Reference
background
PubMed Identifier
15172343
Citation
Mennink-Kersten MA, Donnelly JP, Verweij PE. Detection of circulating galactomannan for the diagnosis and management of invasive aspergillosis. Lancet Infect Dis. 2004 Jun;4(6):349-57. doi: 10.1016/S1473-3099(04)01045-X.
Results Reference
background
PubMed Identifier
11919250
Citation
Herbrecht R, Letscher-Bru V, Oprea C, Lioure B, Waller J, Campos F, Villard O, Liu KL, Natarajan-Ame S, Lutz P, Dufour P, Bergerat JP, Candolfi E. Aspergillus galactomannan detection in the diagnosis of invasive aspergillosis in cancer patients. J Clin Oncol. 2002 Apr 1;20(7):1898-906. doi: 10.1200/JCO.2002.07.004.
Results Reference
background
PubMed Identifier
15352990
Citation
Maertens J, Theunissen K, Verbeken E, Lagrou K, Verhaegen J, Boogaerts M, Eldere JV. Prospective clinical evaluation of lower cut-offs for galactomannan detection in adult neutropenic cancer patients and haematological stem cell transplant recipients. Br J Haematol. 2004 Sep;126(6):852-60. doi: 10.1111/j.1365-2141.2004.05140.x.
Results Reference
background
PubMed Identifier
15243943
Citation
Marr KA, Balajee SA, McLaughlin L, Tabouret M, Bentsen C, Walsh TJ. Detection of galactomannan antigenemia by enzyme immunoassay for the diagnosis of invasive aspergillosis: variables that affect performance. J Infect Dis. 2004 Aug 1;190(3):641-9. doi: 10.1086/422009. Epub 2004 Jul 1.
Results Reference
background
PubMed Identifier
14999640
Citation
Viscoli C, Machetti M, Cappellano P, Bucci B, Bruzzi P, Van Lint MT, Bacigalupo A. False-positive galactomannan platelia Aspergillus test results for patients receiving piperacillin-tazobactam. Clin Infect Dis. 2004 Mar 15;38(6):913-6. doi: 10.1086/382224. Epub 2004 Feb 27.
Results Reference
background
PubMed Identifier
15155189
Citation
Singh N, Obman A, Husain S, Aspinall S, Mietzner S, Stout JE. Reactivity of platelia Aspergillus galactomannan antigen with piperacillin-tazobactam: clinical implications based on achievable concentrations in serum. Antimicrob Agents Chemother. 2004 Jun;48(6):1989-92. doi: 10.1128/AAC.48.6.1989-1992.2004.
Results Reference
background
PubMed Identifier
11180076
Citation
Sulahian A, Boutboul F, Ribaud P, Leblanc T, Lacroix C, Derouin F. Value of antigen detection using an enzyme immunoassay in the diagnosis and prediction of invasive aspergillosis in two adult and pediatric hematology units during a 4-year prospective study. Cancer. 2001 Jan 15;91(2):311-8. doi: 10.1002/1097-0142(20010115)91:23.0.co;2-3.
Results Reference
background
PubMed Identifier
12402199
Citation
Maertens J, Van Eldere J, Verhaegen J, Verbeken E, Verschakelen J, Boogaerts M. Use of circulating galactomannan screening for early diagnosis of invasive aspergillosis in allogeneic stem cell transplant recipients. J Infect Dis. 2002 Nov 1;186(9):1297-306. doi: 10.1086/343804. Epub 2002 Oct 8.
Results Reference
background
PubMed Identifier
10071269
Citation
Heussel CP, Kauczor HU, Heussel GE, Fischer B, Begrich M, Mildenberger P, Thelen M. Pneumonia in febrile neutropenic patients and in bone marrow and blood stem-cell transplant recipients: use of high-resolution computed tomography. J Clin Oncol. 1999 Mar;17(3):796-805. doi: 10.1200/JCO.1999.17.3.796.
Results Reference
background
PubMed Identifier
11731939
Citation
Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14. doi: 10.1086/323335. Epub 2001 Nov 26.
Results Reference
background
PubMed Identifier
10072411
Citation
Walsh TJ, Finberg RW, Arndt C, Hiemenz J, Schwartz C, Bodensteiner D, Pappas P, Seibel N, Greenberg RN, Dummer S, Schuster M, Holcenberg JS. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. National Institute of Allergy and Infectious Diseases Mycoses Study Group. N Engl J Med. 1999 Mar 11;340(10):764-71. doi: 10.1056/NEJM199903113401004.
Results Reference
background
PubMed Identifier
12607556
Citation
Sociedad Espanola de Quimioterapia; Asociacion Espanola de Hematologia y Hemoterapia. [Prophylaxis and treatment of fungal infections in oncohematological patients]. Rev Esp Quimioter. 2002 Dec;15(4):387-401. No abstract available. Spanish.
Results Reference
background
PubMed Identifier
12167683
Citation
Herbrecht R, Denning DW, Patterson TF, Bennett JE, Greene RE, Oestmann JW, Kern WV, Marr KA, Ribaud P, Lortholary O, Sylvester R, Rubin RH, Wingard JR, Stark P, Durand C, Caillot D, Thiel E, Chandrasekar PH, Hodges MR, Schlamm HT, Troke PF, de Pauw B; Invasive Fungal Infections Group of the European Organisation for Research and Treatment of Cancer and the Global Aspergillus Study Group. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis. N Engl J Med. 2002 Aug 8;347(6):408-15. doi: 10.1056/NEJMoa020191.
Results Reference
background
PubMed Identifier
14748799
Citation
Pfaller MA, Diekema DJ; International Fungal Surveillance Participant Group. Twelve years of fluconazole in clinical practice: global trends in species distribution and fluconazole susceptibility of bloodstream isolates of Candida. Clin Microbiol Infect. 2004 Mar;10 Suppl 1:11-23. doi: 10.1111/j.1470-9465.2004.t01-1-00844.x.
Results Reference
background
PubMed Identifier
14699449
Citation
Pappas PG, Rex JH, Sobel JD, Filler SG, Dismukes WE, Walsh TJ, Edwards JE; Infectious Diseases Society of America. Guidelines for treatment of candidiasis. Clin Infect Dis. 2004 Jan 15;38(2):161-89. doi: 10.1086/380796. Epub 2003 Dec 19. No abstract available.
Results Reference
background
PubMed Identifier
1542320
Citation
Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
Results Reference
background
PubMed Identifier
8442620
Citation
Winston DJ, Chandrasekar PH, Lazarus HM, Goodman JL, Silber JL, Horowitz H, Shadduck RK, Rosenfeld CS, Ho WG, Islam MZ, Buell DN. Fluconazole prophylaxis of fungal infections in patients with acute leukemia. Results of a randomized placebo-controlled, double-blind, multicenter trial. Ann Intern Med. 1993 Apr 1;118(7):495-503. doi: 10.7326/0003-4819-118-7-199304010-00003.
Results Reference
background
PubMed Identifier
10064252
Citation
Rotstein C, Bow EJ, Laverdiere M, Ioannou S, Carr D, Moghaddam N. Randomized placebo-controlled trial of fluconazole prophylaxis for neutropenic cancer patients: benefit based on purpose and intensity of cytotoxic therapy. The Canadian Fluconazole Prophylaxis Study Group. Clin Infect Dis. 1999 Feb;28(2):331-40. doi: 10.1086/515128.
Results Reference
background
PubMed Identifier
10808206
Citation
Wolff SN, Fay J, Stevens D, Herzig RH, Pohlman B, Bolwell B, Lynch J, Ericson S, Freytes CO, LeMaistre F, Collins R, Pineiro L, Greer J, Stein R, Goodman SA, Dummer S. Fluconazole vs low-dose amphotericin B for the prevention of fungal infections in patients undergoing bone marrow transplantation: a study of the North American Marrow Transplant Group. Bone Marrow Transplant. 2000 Apr;25(8):853-9. doi: 10.1038/sj.bmt.1702233.
Results Reference
background
PubMed Identifier
7769290
Citation
Slavin MA, Osborne B, Adams R, Levenstein MJ, Schoch HG, Feldman AR, Meyers JD, Bowden RA. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation--a prospective, randomized, double-blind study. J Infect Dis. 1995 Jun;171(6):1545-52. doi: 10.1093/infdis/171.6.1545.
Results Reference
background
PubMed Identifier
11904111
Citation
MacMillan ML, Goodman JL, DeFor TE, Weisdorf DJ. Fluconazole to prevent yeast infections in bone marrow transplantation patients: a randomized trial of high versus reduced dose, and determination of the value of maintenance therapy. Am J Med. 2002 Apr 1;112(5):369-79. doi: 10.1016/s0002-9343(01)01127-5.
Results Reference
background
PubMed Identifier
14525770
Citation
Marr KA, Crippa F, Leisenring W, Hoyle M, Boeckh M, Balajee SA, Nichols WG, Musher B, Corey L. Itraconazole versus fluconazole for prevention of fungal infections in patients receiving allogeneic stem cell transplants. Blood. 2004 Feb 15;103(4):1527-33. doi: 10.1182/blood-2003-08-2644. Epub 2003 Oct 2.
Results Reference
background
Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology

Learn more about this trial

Antifungal Use in Oncohematological Neutropenic Patients

We'll reach out to this number within 24 hrs