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       occurred in 6% (11/173) of patients; seven children were withdrawn from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).