CPA (itraconazole)
Trial question
Is 12-month oral itraconazole superior to 6-month itraconazole in patients with chronic pulmonary aspergillosis?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 164
164 patients (78 female, 86 male).
Inclusion criteria: adult patients with chronic pulmonary aspergillosis who were naive to antifungal treatment.
Key exclusion criteria: receipt of antifungal azoles for > 3 weeks in the preceding 6 months; active mycobacterium tuberculosis or NTM pulmonary disease; other forms of pulmonary aspergillosis.
Interventions
N=83 12-month itraconazole (an oral dose of 400 mg/day for 12 months).
N=81 6-month itraconazole (an oral dose of 400 mg/day for 6 months).
Primary outcome
Relapse at 2 years
10%
38%
38.0 %
28.5 %
19.0 %
9.5 %
0.0 %
12-month
itraconazole
6-month
itraconazole
Significant
decrease ▼
NNT = 3
Significant decrease in relapse at 2 years (10% vs. 38%; ARD -29, 95% CI -16 to -40).
Secondary outcomes
Significantly longer time to first relapse (23 months vs. 18 months; AD 5 months, 95% CI 2.5 to 7.5).
Safety outcomes
No significant differences in nausea, anorexia, ankle edema, other adverse events.
Conclusion
In adult patients with chronic pulmonary aspergillosis who were naive to antifungal treatment, 12-month itraconazole was superior to 6-month itraconazole with respect to relapse at 2 years.
Reference
Inderpaul S Sehgal, Sahajal Dhooria, Valliappan Muthu et al. Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India. Lancet Infect Dis. 2022 Jul;22(7):1052-1061.
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