Isavuconazole for Primary Treatment of Invasive Aspergillosis


Tracking Information

Start Date  ICMJEDecember 2006
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2006)		Overall outcome (clinical, mycological and radiological response)
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00412893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 18, 2006)
  • Overall outcome at different time points and in predefined sub-populations
  • Mycological response
  • Survival rate
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEIsavuconazole for Primary Treatment of Invasive Aspergillosis
Official Title  ICMJEA Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of Isavuconazole Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.
Brief Summary

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Detailed Description

Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain to be a life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. Isavuconazole is not yet registered for the treatment of fungal infections. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi. Patients are randomized to receive either isavuconazole or voriconazole. The study compares the safety and efficacy of both drugs.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Invasive Fungal Infection
  • Aspergillosis
Intervention  ICMJE
  • Drug: Isavuconazole
    Drug treatment
  • Drug: Voriconazole
    Drug treatment
Study Arms / Comparison Groups
  • 1: Experimental
    Isavuconazole
    Intervention: Drug: Isavuconazole
  • 2: Experimental
    Voriconazole
    Intervention: Drug: Voriconazole

Recruitment Information

Estimated Enrollment  ICMJE360
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have probable or proven invasive fungal disease caused by Aspergillus species or other filamentous fungi

Exclusion Criteria:

  • Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
  • Patients with either chronic aspergillosis or aspergilloma
  • Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Markus Heep, MD41-616-061 ext 316markus.heep@basilea.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Egypt,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Peru,   Philippines,   Poland,   Russian Federation,   Saudi Arabia,   Singapore,   South Africa,   Spain,   Switzerland,   Thailand,   Turkey

Administrative Information

NCT ID  ICMJENCT00412893
Responsible PartyMarkus Heep, MD, Basilea Pharmaceutica
Study ID Numbers  ICMJEWSA-CS-004
Study Sponsor  ICMJEBasilea Pharmaceutica
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Markus Heep, MDBasilea Pharmaceutica
Information Provided ByBasilea Pharmaceutica