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M94A0109.TXT
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1994-10-01
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Document 0109
DOCN M94A0109
TI Fluconazole treatment of children with severe fungal infections not
treatable with conventional agents.
DT 9412
AU Fasano C; O'Keeffe J; Gibbs D; International Pharmaceuticals Group,
Pfizer Incorporated, New; York, New York 10017.
SO Eur J Clin Microbiol Infect Dis. 1994 Apr;13(4):344-7. Unique Identifier
: AIDSLINE MED/94349967
AB Fluconazole was evaluated prospectively in 173 children aged between 4
months and 16 years in whom conventional antifungal therapy was
ineffective or contraindicated. Children entered the study on an
individual compassionate request basis for treatment of confirmed or
presumed fungal infection or for prophylaxis of fungal infections.
Sixty-two children had cancer, 40 had undergone transplantation, 14 had
AIDS and 52 had other conditions. The mean fluconazole dosage was 3.4
mg/kg/day (range 0.16-11.1 mg/kg/day) and the mean duration of therapy
was 36 days (range 1-340 days). Efficacy was evaluated in 63 children
with confirmed fungal infection as documented by the presence of a
fungal pathogen at baseline; clinical cure or improvement was achieved
in 83% (52/63), pathogen eradication in 73% (43/59). All 173 children
were assessed for safety. Related or possibly related adverse events
occurred in 6% (11/173) of patients; seven children were withdrawn from
therapy because of adverse events. Results of this study demonstrate
that the clinical efficacy and safety profile of fluconazole in the
treatment of fungal infections in children are favorable, results being
similar to those obtained in adults.
DE Adolescence Age Factors AIDS-Related Opportunistic Infections/*DRUG
THERAPY Body Weight Candida/ISOLATION & PURIF Candidiasis/*DRUG
THERAPY/MICROBIOLOGY Child Child, Preschool Female
Fluconazole/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE
Human Immunocompromised Host Infant Male Mycoses/*DRUG
THERAPY/MICROBIOLOGY Neoplasms/COMPLICATIONS Prospective Studies Time
Factors CLINICAL TRIAL JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).