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Intravenous and Oral Itraconazole versus Intravenous Amphotericin B Deoxycholate as Empirical Antifungal Therapy for Persistent Fever in Neutropenic Patients with Cancer Who Are Receiving Broad-Spectrum Antibacterial Therapy: A Randomized, Controlled Trial

Marc Boogaerts, MD, PhD; Drew J. Winston, MD; Eric J. Bow, MD; Gary Garber, MD; Annette C. Reboli, MD; Anthony P. Schwarer, MD, FRACP; Nicolas Novitzky, MD, PhD; Angelika Boehme, MD; Elisabeth Chwetzoff, MD; Karel De Beule, RPh, the Itraconazole Neutropenia Study Group*
[+] Article and Author Information

From University Hospital, Leuven, Belgium; University of California, Los Angeles, Medical Center, Los Angeles, California; University of Manitoba, Winnipeg, Manitoba, Canada; Ottawa Hospital–General Campus, University of Ottawa, Ottawa, Ontario, Canada; Robert Wood Johnson Medical School at Camden, Cooper Hospital, Camden, New Jersey; Alfred Hospital, Melbourne, Australia; Groote Schuur Hospital, Cape Town, South Africa; University Hospital, Frankfurt, Germany; Janssen Research Foundation, Issy-les-Moulineaux, France; and Janssen Research Foundation, Beerse, Belgium.


Grant Support: By Janssen Research Foundation, Beerse, Belgium.

Requests for Single Reprints: Marc Boogaerts, MD, PhD, Department of Hematology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium; e-mail, marc.boogaerts@uz.kuleuven.ac.be.

Current Author Addresses: Dr. Boogaerts: Department of Hematology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.

Dr. Winston: Transplantation Biology Program, UCLA School of Medicine, Center for the Health Sciences, 10833 Le Conte Avenue, Los Angeles, CA 90095-1678.

Dr. Bow: Department of Internal Medicine, The University of Manitoba, Health Sciences Centre, 820 Sherbrooke Street, Winnipeg, Manitoba R3A 1R9, Canada.

Dr. Garber: Division of Infectious Disease, Ottawa Hospital-General Campus, University of Ottawa, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.

Dr. Reboli: Department of Medicine, Robert Wood Johnson Medical School at Camden, Cooper Hospital, Education and Research Building, 401 Haddon Avenue, Room 270, Camden, NJ 08103.

Dr. Schwarer: Bone Marrow Transplant Programme, Alfred Hospital, Commercial Road, Melbourne, Victoria 3181, Australia.

Dr. Novitzky: Department of Haematology, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Anzio Road, Observatory, Cape Town 7925, South Africa.

Dr. Boehme: Medical Clinic III, J.W. Goethe-University, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.

Dr. Chwetzoff: Bømloveien 16, 4027 Stavanger, Norway.

Dr. De Beule: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

Author Contributions: Conception and design: M. Boogaerts, D.J. Winston, E. Chwetzoff, K. De Beule.

Analysis and interpretation of the data: M. Boogaerts, D.J. Winston, E.J. Bow, G. Garber, A.P. Schwarer, N. Novitzky, K. De Beule.

Drafting of the article: M. Boogaerts, D.J. Winston, E.J. Bow, G. Garber, A.P. Schwarer, N. Novitzky, K. De Beule.

Critical revision of the article for important intellectual content: M. Boogaerts, D.J. Winston, E.J. Bow, G. Garber, A.C. Reboli, A.P. Schwarer, N. Novitzky, A. Boehme.

Final approval of the article: M. Boogaerts, D.J. Winston, E.J. Bow, G. Garber, A.C. Reboli, A.P. Schwarer, N. Novitzky, A. Boehme, E. Chwetzoff, K. De Beule.

Provision of study materials or patients: D.J. Winston, G. Garber, A.C. Reboli, A.P. Schwarer, N. Novitzky, A. Boehme.

Statistical expertise: E.J. Bow.

Collection and assembly of data: D.J. Winston.


Ann Intern Med. 2001;135(6):412-422. doi:10.7326/0003-4819-135-6-200109180-00010
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Prolonged neutropenia is a major risk factor for invasive fungal infection (16). The incidence among neutropenic patients with cancer who are receiving intensive cytotoxic therapy ranges from 2% to 47%, depending on other concomitant risk factors (7). Mortality rates range from 35% to 90% (8). Fever may be the only clinical sign of infection, and definitive diagnosis is often problematic. Empirical therapy with amphotericin B deoxycholate reduces the relative risk for documented infection by 50% to 80% and overall mortality rates by 23% to 45% (12, 910). This practice is now standard in neutropenic patients with cancer who have persistent fever that does not respond to 3 to 7 days of treatment with broad-spectrum antibiotics (11).

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Grahic Jump Location
Figure.
Creatinine clearance as a function of time on study in itraconazole recipients (circles) and amphotericin B recipients (squares).(23)

Creatinine clearance was calculated from serum creatinine concentration, age, body weight, and sex by using the formula of Cockcroft and Gault . Error bars represent 95% CIs. To convert creatinine clearance to mL/s, multiply by 0.0167.

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Summary for Patients

Itraconazole and Amphotericin B To Treat Fungal Infections in Patients with Cancer Who Are Receiving Chemotherapy

The summary below is from the full report titled “Intravenous and Oral Itraconazole versus Intravenous Amphotericin B Deoxycholate as Empirical Antifungal Therapy for Persistent Fever in Neutropenic Patients with Cancer Who Are Receiving Broad-Spectrum Antibacterial Therapy. A Randomized, Controlled Trial.” It is in the 18 September 2001 issue of Annals of Internal Medicine (volume 135, pages 412-422). The authors are M Boogaerts, DJ Winston, EJ Bow, G Garber, AC Reboli, AP Schwarer, N Novitzky, A Boehme, E Chwetzoff, K De Beule, and the Itraconazole Neutropenia Study Group.

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