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Document 0319
DOCN M9490319
TI NIAID Mycoses Study Group Multicenter Trial of Oral Itraconazole Therapy
for Invasive Aspergillosis.
DT 9411
AU Denning DW; Lee JY; Hostetler JS; Pappas P; Kauffman CA; Dewsnup DH;
Galgiani JN; Graybill JR; Sugar AM; Catanzaro A; et al; Department of
Medicine, Santa Clara Valley Medical Center, San; Jose, California
95128.
SO Am J Med. 1994 Aug;97(2):135-44. Unique Identifier : AIDSLINE
MED/94337780
AB BACKGROUND: Invasive aspergillosis is the most common invasive mould
infection and a major cause of mortality in immunocompromised patients.
Response to amphotericin B, the only antifungal agent licensed in the
United States for the treatment of aspergillosis, is suboptimal.
METHODS: A multicenter open study with strict entry criteria for
invasive aspergillosis evaluated oral itraconazole (600 mg/d for 4 days
followed by 400 mg/d) in patients with various underlying conditions.
Response was based on clinical and radiologic criteria plus
microbiology, histopathology, and autopsy data. Responses were
categorized as complete, partial, or stable. Failure was categorized as
an itraconazole failure or overall failure. RESULTS: Our study
population consisted of 76 evaluable patients. Therapy duration varied
from 0.3 to 97 weeks (median 46). At the end of treatment, 30 (39%)
patients had a complete or partial response, and 3 (4%) had a stable
response, and in 20 patients (26%), the protocol therapy was
discontinued early (at 0.6 to 54.3 weeks) because of a worsening
clinical course or death due to aspergillosis (itraconazole failure).
Twenty-three (30%) patients withdrew for other reasons including
possible toxicity (7%) and death due to another cause but without
resolution of aspergillosis (20%). Itraconazole failure rates varied
widely according to site of disease and underlying disease group: 14%
for pulmonary and tracheobronchial disease, 50% for sinus disease, 63%
for central nervous system disease, and 44% for other sites; 7% in solid
organ transplant, 29% in allogeneic bone marrow transplant patients, and
14% in those with prolonged granulocytopenia (median 19 days), 44% in
AIDS patients, and 32% in other host groups. The relapse rates among
those who completed therapy and those who discontinued early for
possible toxicity were 12% and 40%, respectively; all were still
immunosuppressed. CONCLUSION: Oral itraconazole is a useful alternative
therapy for invasive aspergillosis with response rates apparently
comparable to amphotericin B. Relapse in immunocompromised patients may
be a problem. Controlled trials are necessary to fully assess the role
of itraconazole in the treatment of invasive aspergillosis.
DE Administration, Oral Agranulocytosis/DRUG THERAPY/MICROBIOLOGY
Aspergillosis/*DRUG THERAPY AIDS-Related Opportunistic Infections/DRUG
THERAPY/MICROBIOLOGY Central Nervous System Diseases/DRUG
THERAPY/MICROBIOLOGY Chi-Square Distribution Female Human
Itraconazole/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE
Male Middle Age Organ Transplantation Recurrence Respiratory Tract
Infections/DRUG THERAPY/MICROBIOLOGY Support, Non-U.S. Gov't Support,
U.S. Gov't, P.H.S. Treatment Outcome CLINICAL TRIAL JOURNAL ARTICLE
MULTICENTER STUDY
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).