Document 0108
 DOCN  M94A0108
 TI    Efficacy and safety of fluconazole in the treatment of systemic fungal
       infections in pediatric patients. Multicentre Study Group.
 DT    9412
 AU    Presterl E; Graninger W; Department of Medicine I, University of Vienna,
       Austria.
 SO    Eur J Clin Microbiol Infect Dis. 1994 Apr;13(4):347-51. Unique
       Identifier : AIDSLINE MED/94349968
 AB    In a non-comparative multicentre trial 51 patients aged 24 days to 17
       years received treatment with intravenous or oral fluconazole for
       suspected systemic fungal infections. Twenty-seven patients had
       confirmed infections, 26 being confirmed mycologically and 1
       histologically. All isolates were Candida species. Of the 43 clinically
       assessed patients, 30 were considered cured, 7 improved and 6
       experienced failure of therapy. Of 27 patients with confirmed fungal
       infections, 25 were assessed mycologically and all but one were
       considered cured. Of the six patients experiencing clinical failure, two
       had a confirmed infection and only one of these experienced mycological
       failure. This patient had a primary diagnosis of candidemia with
       persistence of Candida albicans and Candida parapsilosis. All 51
       patients were evaluable for safety. No treatment-related adverse events
       required termination of treatment. Treatment-related side effects
       (diarrhea, vomiting, deafness) were reported by three of 51 patients,
       three patients had laboratory test abnormalities possibly related to
       fluconazole treatment, including elevation of liver enzyme levels and of
       the eosinophil count. Results of this study confirm the efficacy and
       safety of fluconazole in the treatment of pediatric patients with severe
       fungal infection.
 DE    Adolescence  Age Factors  AIDS-Related Opportunistic Infections/DRUG
       THERAPY  Candida/ISOLATION & PURIF  Candidiasis/*DRUG
       THERAPY/MICROBIOLOGY  Child  Child, Preschool  Female
       Fluconazole/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       Fungemia/DRUG THERAPY  Human  Immunocompromised Host  Infant  Infant,
       Newborn  Male  Risk Factors  CLINICAL TRIAL  JOURNAL ARTICLE
       MULTICENTER STUDY

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