Journal of Antimicrobial Chemotherapy, Vol 40, 855-862, Copyright © 1997 by The British Society for Antimicrobial Chemotherapy
AH Groll, G Just-Nuebling, M Kurz, C Mueller, U Nowak-Goettl, D Schwabe, PM Shah and B Kornhuber
An open, prospective, randomized pilot study was performed to assess the
efficacy and safety of oral fluconazole 3 mg/kg once daily compared with
oral nystatin 50,000 units/kg/day in four divided doses in preventing
candida infections in 50 children undergoing remission induction or
consolidation therapy for cancer. In 21 of 25 fluconazole- treated and 20
of 25 nystatin-treated patients the overall outcome of prophylaxis was
clearly successful. Mild and transient oropharyngeal candidosis was
observed in two and three patients in the fluconazole and nystatin groups
respectively. One patient randomized to fluconazole and two patients
randomized to nystatin required empirical treatment with amphotericin B and
one patient assigned to fluconazole developed tissue-proven candida
colitis. Initially non-colonized patients remained yeast-free throughout
treatment with no differences between the two study arms. Initially
colonized patients stayed colonized throughout treatment although at the
end of the study, more patients randomized to nystatin were still
harbouring yeasts (P = 0.05). Almost exclusively, Candida albicans (95%)
was isolated. A change in species was observed in one patient in each arm
of the study. Candida krusei or Candida glabrata were not encountered.
Transient elevations of hepatic transaminases were more common in the
fluconazole group, although not statistically significant (28% vs 12%, P =
0.15). Reversible grade I gastrointestinal and skin symptoms were observed
in four patients randomized to fluconazole (16 vs 0%, P < 0.05).
Fluconazole was as safe and effective as nystatin in controlling yeast
colonization and in preventing superficial and invasive candida infections
and the empirical use of amphotericin B in children and adolescents
undergoing intensive chemotherapy for cancer.
ORIGINAL ARTICLES
Fluconazole versus nystatin in the prevention of candida infections in children and adolescents undergoing remission induction or consolidation chemotherapy for cancer
Department of Paediatrics, Johann Wolfgang Goethe University Hospital, Frankfurt am Main, Germany. agroll@pbmac.nci.nih.gov
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