Anidulafungin was noninferior to fluconazole for invasive candidiasis.

M e t h o d s Design: Randomized, controlled, noninferiority trial. Allocation: {Concealed}†.* Blinding: Blinded.* Setting: 47 institutions in 6 countries in Europe and North America. Follow-up period: 6 weeks after completion of therapy. Patients: 261 patients ≥ 16 years of age who had candidemia (≥ 1 positive blood culture) or other forms of invasive candidiasis (a positive culture obtained from a sterile site) within 96 hours of enrollment and ≥ 1 of fever, hypothermia, hypotension, local signs and symptoms, or radiologic findings of invasive candidiasis. Exclusion criteria were > 48 hours of systemic antifungal therapy, prophylactic administration of any azole for > 1 week within 30 days, refractory candida infection, elevated hepatic enzymes, Candida krusei infection, osteomyelitis, endocarditis, or meningitis due to Candida infection. Intervention: Intravenous (IV) anidulafungin, 200 mg on day 1 and then 100 mg/d (n = 132), or IV fluconazole, 800 mg on day 1 and then 400 mg/d (n = 129), for 14 to 42 days and for ≥ 14 days after negative blood culture and improvement in signs and symptoms. Outcomes: Global treatment response based on clinical success (resolution of signs and symptoms and no need for additional systemic antifungal therapy) and microbiologic success (eradication of Candida species present at baseline on follow-up culture or presumed eradication if no available culture and successful clinical response) at the end of IV therapy. Secondary outcomes included death and adverse events. Patient follow-up: 94% (mean age 58 y, 51% men) were included in the modified intention-to-treat analysis (received ≥ 1 dose of study medication), and 98% were included in the intention-to-treat analysis.