R. Mouy et al., LONG-TERM ITRACONAZOLE PROPHYLAXIS AGAINST ASPERGILLUS INFECTIONS IN 32 PATIENTS WITH CHRONIC GRANULOMATOUS-DISEASE, The Journal of pediatrics, 125(6), 1994, pp. 998-1003
We conducted a prospective, open study of oral itraconazole therapy (5
and then 10 mg/kg per day) to assess tolerance and potential efficacy
in preventing fungal infections in patients with chronic granulomatou
s disease. Thirty-two patients were enrolled In one center between 198
5 and 1991. Tolerance was excellent in all cases. Poor compliance was
suspected In three cases. Two patients were excluded from efficacy ana
lysis because itraconazole was used as part of therapy for pulmonary a
spergillosis. Of 30 patients, 3 developed a fungal (Aspergillus) lung
infection, an incidence 3.4/100 patient-years versus 11.5 in a histori
cal control group that did not receive any prophylaxis (p = 0.13) and
9.55 in a historical group of patients who received daily ketoconazole
prophylaxis (p = 0.19). The percentage of patients infected with Aspe
rgillus was significantly different: 10% in the itraconazole group ver
sus 34.4% in the untreated group (P = 0.013). These results require fu
rther evaluation through a comparative randomized trial to assess the
possible benefit of itraconazole prophylaxis in patients with chronic
granulomatous disease.