The pharmacokinetics of ketoconazole in severely immunocompromised patients

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Abstract
Forty patients severely immunocompromised because of the nature of their underlying disease (marrow aplasia, acute leukaemia or solid tumour) and/or the treatment they were receiving, received ketoconazole 400 mg daily. All patients also received gut decontamination with non-absorbable antibiotics, skin antisepsis, sterile food and oral co-trimoxazole. Mean (±S.D.) peak serum ketoconazole levels of 5·14±1·4 mg/l occurred 3 h after drug intake. In patients not receiving an allogeneic bone marrow transplant (BMT), the mean serum level at 2 h post-dose remained in the range of 3 to 5 mg/l during prolonged therapy. In contrast, serum ketoconazole levels in allogeneic BMT patients declined during continued treatment. In addition, the incidence of fungal infections was significantly higher in allogeneic-BMT patients than in the other group (P<0·005).