Phase 3 N=450 Randomized Double-blind Treatment

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

Candidiasis, Invasive · Candidemia · Mycoses

Bottom Line

View on ClinicalTrials.gov: NCT00413218 ↗

Enrolled (actual)

450

Serious AEs

49.6%

Results posted

Aug 2017

Primary outcome: Primary: Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use — 60.3; 71.1 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Isavuconazole (Drug); Caspofungin (Drug); Voriconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Astellas Pharma Inc
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use	60.3; 71.1	—
SECONDARY Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)	54.8; 57.2	—
SECONDARY Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2	61.3; 72.1; 43.2; 48.3	—
SECONDARY Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)	76.4; 84.1; 76.4; 84.6; 67.8; 67.7	—
SECONDARY Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)	70.9; 85.6; 71.9; 87.6; 66.8; 65.7	—
SECONDARY Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator	61.3; 72.1; 72.9; 81.1	—
SECONDARY Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator	54.3; 64.7; 70.9; 78.6	—
SECONDARY All-Cause Mortality (ACM) at Day 14 and Day 56	14.6; 12.4; 30.7; 29.9	—
SECONDARY Time to First Confirmed Negative Culture	4.0; 3.0	—

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00413218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.