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NCT00105144 Clinical Trial

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

Candidiasis Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00105144
Other study ID # 03-0-192
Secondary ID
Status Completed
Phase Phase 3
First received March 7, 2005
Last updated September 17, 2014
Start date September 2004
Est. completion date April 2006

Study information
Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBrazil: National Health Surveillance AgencyGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia: Ministry of HealthCanada: Health CanadaBelgium: Ministry of Social Affairs, Public Health and the EnvironmentSpain: Ministry of HealthPoland: Ministry of HealthCzech Republic: State Institute for Drug ControlCroatia: Ministry of Health and Social CareNetherlands: Medicines Evaluation Board (MEB)Switzerland: SwissmedicAustria: Federal Office for Safety in Health Care
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Description:

The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Other known NCT identifiers
  • NCT00235742

Recruitment information / eligibility
Status Completed
Enrollment 611
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have candidemia or invasive candidiasis.

Exclusion Criteria:

- Patients who have received an echinocandin within one month prior to study entry.

- Patients who have received more than two days of prior systemic antifungal therapy for the current infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Micafungin
IV
• Caspofungin
IV

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Canada,  Croatia,  Czech Republic,  France,  Germany,  India,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Pappas PG, Rotstein CM, Betts RF, Nucci M, Talwar D, De Waele JJ, Vazquez JA, Dupont BF, Horn DL, Ostrosky-Zeichner L, Reboli AC, Suh B, Digumarti R, Wu C, Kovanda LL, Arnold LJ, Buell DN. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007 Oct 1;45(7):883-93. Epub 2007 Aug 29. Erratum in: Clin Infect Dis. 2008 Jul 15;47(2):302. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy End of therapy and 6 weeks post-treatment No
Secondary Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy End of therapy and 6 weeks post-treatment No
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