title: A double-blind, randomized, placebo-controlled trial of itraconazole capsules as antifungal prophylaxis for neutropenic patients.
abstract: To evaluate the efficacy of itraconazole capsules in prophylaxis for fungal infections in neutropenic patients, we conducted a prospective, double-blind, placebo-controlled, randomized trial. Patients with hematologic malignancies or those who received autologous bone marrow transplants were assigned either a regimen of itraconazole (100 mg orally twice daily; n=104) or of placebo (n=106). Overall, fungal infections (superficial or systemic) occurred more frequently in the placebo group (15% vs. 6%; P=.03). There were no differences in the empirical use of amphotericin B or systemic fungal infections. Among patients with neutropenia that was profound (<100 neutrophils/mm3) and prolonged (for at least 7 days), those receiving itraconazole used less empirical amphotericin B (22% vs. 61%; P=.0001) and developed fewer systemic fungal infections (6% vs. 19%; P=.04). For patients with profound and prolonged neutropenia, itraconazole capsules at the dosage of 100 mg every 12 h reduce the frequency of systemic fungal infections and the use of empirical amphotericin B.
authors.affiliation: Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. mnucci@plugue.com.br
authors.forename: M
authors.initials: M
authors.lastname: Nucci
authors.forename: I
authors.initials: I
authors.lastname: Biasoli
authors.forename: T
authors.initials: T
authors.lastname: Akiti
authors.forename: F
authors.initials: F
authors.lastname: Silveira
authors.forename: C
authors.initials: C
authors.lastname: Solza
authors.forename: G
authors.initials: G
authors.lastname: Barreiros
authors.forename: N
authors.initials: N
authors.lastname: Spector
authors.forename: A
authors.initials: A
authors.lastname: Derossi
authors.forename: W
authors.initials: W
authors.lastname: Pulcheri
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage; D000935:Antifungal Agents / Q000008:administration & dosage*; D001228:Aspergillosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D016026:Bone Marrow Transplantation; D002177:Candidiasis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D016469:Fungemia / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D019337:Hematologic Neoplasms / Q000150:complications / Q000628:therapy; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000150:complications* / Q000401:mortality; D011446:Prospective Studies; D015996:Survival Rate; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole; D000666:Amphotericin B