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

Astellas

Status and phase: Completed; Phase 3

Conditions: Candidemia; Candidiasis, Invasive; Mycoses

Treatments: Drug: Caspofungin; Drug: Voriconazole; Drug: Isavuconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413218

9766-CL-0105

WSA-CS-008 (Other Identifier)

2006-003951-18 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Full description

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

Isavuconazole (ISA)

Experimental group

Description:

Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.

Treatment:

Drug: Isavuconazole

Caspofungin (CAS)/Voriconazole

Active Comparator group

Description:

Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.

Treatment:

Drug: Voriconazole

Drug: Caspofungin