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

NCT00413218 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-12-10

Study results available
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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.

Conditions

  • Candidiasis, Invasive
  • Candidemia
  • Mycoses

Interventions

DRUG

Isavuconazole

Administered by intravenous infusion.

DRUG

Caspofungin

Administered by intravenous infusion.

DRUG

Voriconazole

Administered by intravenous infusion.

Sponsors & Collaborators

  • Basilea Pharmaceutica

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-08
Primary Completion
2015-03-03
Completion
2015-03-03

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Lebanon
  • Malaysia
  • Mexico
  • New Zealand
  • Philippines
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Switzerland
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413218 on ClinicalTrials.gov