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The prophylactic activity of the liphophilic triazole itraconazole was evaluated in systemic aspergillosis and sytemic candidosis in guinea-pigs and in vaginal candidosis in rats. Systemic invasive aspergillosis in guinea-pigs was obtained by intravenous inoculation of Aspergillus fumigatus, 25,000 CFU/g body weight. The administration of 4 doses of itraconazole, 5 mg/kg, before infection was able to prolong the survival of the animals compared with the excipient- treated group (p < 0.001; Mann-Whitney U-test, 2-tailed probability). Systemic and disseminated candidosis in guinea-pigs was obtained by intravenous inoculation of Candida albicans, 1,000, 2,000 or 4,000 CFU/g body weight. Oral prophylaxis with itraconazole, 5 or 10 mg/kg, or with the excipient was given for 1, 2, or 3 days. All excipient-treated animals (n = 38) showed skin folliculitis and gave positive cultures of the skin and kidneys; the number of CFU/g organ weight was higher with heavier inocula. In the itraconazole-treated animals (n = 114), Candida folliculitis was absent in 89%, and skin and kidney cultures were negative in 84% and 82%, repectively. In animals given the higher dose of itraconazole and inoculated with 1,000 or 2,000 CFU/g body weight (n = 60), however, Candida folliculitis was absent in 97%, and skin and kidney cultures were negative in 93% and 88%, respectively. The effectiveness of itraconazole was also related to the number of treatments before inoculation. Oral itraconazole was more effective than parenteral amphotericin B, 1.25 or 2.5 mg/kg, given 24 h and 1 h before inoculation. Female castrated rats maintained in permanent pseudo-oestrus by oestrogen injections were infected intravaginally with C. albicans and pre-treated orally with the excipient or with itraconazole, 1.25-40 mg/kg, in various regimens at 1, 24, 48 and 72 h before infection with 1, 2 or 3 doses. The animals were protected against infection at higher doses or when more than 1 dose was administered. No drug-related side-effects were observed. The broad-spectrum therapeutic value of itraconazole is well established. Prophylaxis with this antifungal agent opens new possibilities for the prevention of chronic diseases and for the protection of immunocompromised patients.

Oral Prophylaxis with Itraconazole of Experimental Aspergillus and Candida Infections