Isavuconazole in the Treatment of Candidemia and Other Invasive Candida Infections


Tracking Information

Start Date  ICMJEDecember 2006
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2006)		Overall response: Resolution of signs and symptoms of infection plus mycological (presumed) eradication
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00413218 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 18, 2006)
  • Mycological response
  • Time to first confirmed negative culture
  • All-cause mortality
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEIsavuconazole in the Treatment of Candidemia and Other Invasive Candida Infections
Official Title  ICMJEA Phase III, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Isavuconazole Versus Caspofungin Followed by Voriconazole in the Treatment of Candidemia and Other Invasive Candida Infections
Brief 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.

Detailed 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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Mycoses
  • Candidiasis
Intervention  ICMJE
  • Drug: Isavuconazole
    Drug treatment
  • Drug: Caspofungin followed by Voriconazole
    Drug treatment
Study Arms / Comparison Groups
  • 1: Experimental
    Isavuconazole
    Intervention: Drug: Isavuconazole
  • 2: Active Comparator
    Caspofungin followed by Voriconazole
    Intervention: Drug: Caspofungin followed by Voriconazole

Recruitment Information

Estimated Enrollment  ICMJE526
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with systemic candida infection
  • Positive blood or deep tissue culture.

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.
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,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Switzerland,   Thailand,   Turkey
 

Administrative Information

NCT ID  ICMJENCT00413218
Responsible PartyMarkus Heep, MD, Basilea Pharmaceutica
Study ID Numbers  ICMJEWSA-CS-008
Study Sponsor  ICMJEBasilea Pharmaceutica
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Markus Heep, MDBasilea Pharmaceutica
Information Provided ByBasilea Pharmaceutica