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Does ketoconazole prevent fungal infection in children treated with high dose chemotherapy and bone marrow transplantation? Results of a randomized placebo-controlled trial.

Between August 1985 and October 1988 125 children who were candidates for a bone marrow transplantation entered a randomized double-blind placebo-controlled trial (63 children in ketoconazole (K) group and 62 children in placebo (P) group) to evaluate the efficacy of ketoconazole in decreasing the incidence of digestive yeast colonization. Among the 38 children who were initially colonized, the proportion of children who became decolonized was higher (p less than 0.05) in group K (47%) than in group P (16%). Among the 87 children without initial colonization, the proportion of children in whom digestive colonization occurred was lower (p less than 0.01) in group K (20%) than in group P (49%). Three children in group K (5%) and six children in group P (9%) developed a documented fungal infection (NS). Thirty-nine children in each group developed a fever of unknown origin which did not respond to a 7-day course of antibiotherapy. One hundred and three children received amphotericin B (Ampho B) (83% in group K and 82% in group P). The mean duration (+/- SD) of Ampho B was similar in group K (28 +/- 26 days) and in group P (28 +/- 25 days). The mean total dose of Ampho B was similar in group K (475.5 +/- 1060 mg) and in group P (540.4 +/- 979 mg). The actuarial survival from the day of randomization until bone marrow recovery was not different in the two groups. We conclude that ketoconazole is efficient in preventing gut yeast colonization but does not reduce the incidence of fungal documented infections and fevers of unknown origin unresponsive to antibiotherapy which necessitate empirical coverage and treatment with Ampho B.