Randomized trial with itraconazole, ketoconazole and sulfadiazine in paracoccidioidomycosis.

Author(s): Shikanai-Yasuda MA, Benard G, Higaki Y, Del Negro GM, Hoo S, Vaccari EH, Gryschek RC, Segurado AA, Barone AA, Andrade DR

Affiliation(s): Department of Infectious and Parasitic Diseases, School of Medicine, Sao Paulo University, Brazil. dmip.secr@hcnet.usp.br

Publication date & source: 2002-08, Med Mycol., 40(4):411-7.

Publication type: Clinical Trial; Randomized Controlled Trial

Forty-two patients with active paracoccidioidomycosis were randomized to receive itraconazole (50-100 mg d(-1)), ketoconazole (200-400 mg d(-1)) or sulfadiazine (100-150 mg kg d(-1) up to 6 g d(-1)) for 4-6 months, followed by slow release sulfa until negativity of serological tests. All 14 patients in itraconazole and sulfadiazine groups and 13 in the ketoconazole group showed an adequate clinical response to the chemotherapy. One patient in the latter group showed treatment failure according to clinical and mycological criteria. The test of the hypothesis that the drugs reduced antibody levels up to ten months of treatment showed a p value equal to 0.0001 for itraconazole, 0.017 for ketoconazole and 0.0012 for sulfadiazine; this reduction was similar for the three groups. In this first randomized study for the treatment of paracoccidioidomycosis we could not show superiority of any one regimen over the others in the clinical and serological responses of patients with the moderately severe form of the disease.