NCT00413218

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00413218

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Candidiasis, Invasive

Candidemia

Mycoses

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Isavuconazole
- Description: Administered by intravenous infusion.
- Arm Group Labels: Isavuconazole (ISA)
- Type: DRUG
- Name: Caspofungin
- Description: Administered by intravenous infusion.
- Arm Group Labels: Caspofungin (CAS)/Voriconazole
- Type: DRUG
- Name: Voriconazole
- Description: Administered by intravenous infusion.
- Arm Group Labels: Caspofungin (CAS)/Voriconazole

Sponsor

Astellas Pharma Inc