Ketoconazole prevents Candida sepsis in critically ill surgical patients
G. J. Slotman and K. W. Burchard
We conducted a prospective, randomized, double-blind, placebo-controlled
study to determine whether or not ketoconazole could prevent yeast
colonization or invasion in critically ill adult surgical patients.
Fifty-seven patients in a surgical intensive care unit (SICU) with three or
more clinical risk factors for Candida infection were randomized to receive
ketoconazole, 200 mg via the gastrointestinal tract daily (27 patients), or
placebo (30 patients). Patients with hepatic dysfunction were excluded. The
study was continued for 21 days or until one week after discharge from the
SICU, whichever was longer. Stool cultures were obtained every three days
and other cultures as indicated clinically. Patients were observed for
yeast colonization (sputum, urine, stool, or wound) and invasion (fungemia
or deep tissue focus). The incidence of Candida colonization was
significantly lower in the ketoconazole group than the placebo group.
Invasive yeast sepsis developed in five (17%) of the placebo-treated
patients and in no patient in the ketoconazole group, a significant
difference. Length of stay in the SICU was significantly lower in the
ketoconazole group, as were the basic SICU patient charges. Sixty percent
of the patients with invasive fungal sepsis died.