Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Candida infections, representing approximately 80% of all major systemic fungal infections,
are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate
of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study
investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are
randomized to isavuconazole and the reference regimen. Patients with a positive blood- or
deep tissue culture of candida fungi can be included.

Inclusion Criteria:

- Patients with candidemia or with an invasive Candida infection

- Presence of fever, hypothermia or other appropriate local sign of infection

- Female patients must be non-lactating and at no risk of pregnancy

Exclusion Criteria:

- Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal,
esophageal or genital candidiasis; or candidal lower urinary tract infection or
Candida isolated solely from respiratory tract specimens

- Patients with candidemia who failed a previous antifungal therapy for the same
infection

- Patients previously enrolled in a phase III study with isavuconazole

- Patients with a body weight <40kg