Long-term itraconazole prophylaxis against Aspergillus infections in thirty-two patients with chronic granulomatous disease
Related Experiment Videos
1Unité d'Immunologie et d'Hématologie, Hôpital des Enfants Malades, Paris, France.
Abstract:
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 granulomatous disease. Thirty-two patients were enrolled in one center between 1985 and 1991. Tolerance was excellent in all cases. Poor compliance was suspected in three cases. Two patients were excluded from efficacy analysis because itraconazole was used as part of therapy for pulmonary aspergillosis. Of 30 patients, 3 developed a fungal (Aspergillus) lung infection, an incidence 3.4/100 patient-years versus 11.5 in a historical 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 Aspergillus was significantly different: 10% in the itraconazole group versus 34.4% in the untreated group (p = 0.013). These results require further evaluation through a comparative randomized trial to assess the possible benefit of itraconazole prophylaxis in patients with chronic granulomatous disease.
Insights
Itraconazole prophylaxis shows promise in preventing fungal infections in patients with chronic granulomatous disease. Further randomized trials are needed to confirm its benefits against Aspergillus infections.
Area of Science:
- Mycology
- Immunology
- Clinical Pharmacology
Background:
- Chronic granulomatous disease (CGD) patients are highly susceptible to invasive fungal infections.
- Prophylactic antifungal therapy is crucial for managing CGD complications.
- Previous prophylaxis strategies have limitations.
Purpose of the Study:
- To evaluate the tolerance and efficacy of oral itraconazole for preventing fungal infections in CGD patients.
- To assess itraconazole's potential role in reducing Aspergillus infections.
- To establish a basis for future randomized controlled trials.
Main Methods:
- Prospective, open-label study involving 32 CGD patients.
- Oral itraconazole administered at 5 mg/kg/day, then increased to 10 mg/kg/day.
- Efficacy compared against historical untreated and ketoconazole-prophylaxis groups.
- Incidence of fungal infections, particularly Aspergillus, was monitored.
Main Results:
- Excellent tolerance to itraconazole was observed in all patients.
- Three out of 30 patients developed invasive pulmonary aspergillosis.
- The incidence of Aspergillus lung infections was lower in the itraconazole group (3.4/100 patient-years) compared to historical controls.
- A significantly lower percentage of patients (10%) in the itraconazole group were infected with Aspergillus versus the untreated group (34.4%, p=0.013).
Conclusions:
- Oral itraconazole demonstrates good tolerance and potential efficacy in preventing fungal infections in CGD.
- Itraconazole prophylaxis may significantly reduce Aspergillus infections in CGD patients.
- Further randomized controlled trials are warranted to confirm these findings and establish itraconazole's role in CGD management.