Clinical Trials Logo

Clinical Trial Summary

To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia


Clinical Trial Description

Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00189709
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 3
Start date August 2004
Completion date July 2006

See also
  Status Clinical Trial Phase
Terminated NCT01982071 - A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia Phase 4
Completed NCT02244606 - Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis Phase 2
Completed NCT02163889 - Serial Therapeutic and Antifungal Monitoring Protocol
Recruiting NCT01438216 - Anidulafungin Pharmacokinetics in Intensive Care Unit Patients N/A
Not yet recruiting NCT01249313 - Risk Factor and Outcome of Candidemia N/A
Terminated NCT01213823 - Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins Phase 4
Completed NCT00940017 - A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects Phase 4
Completed NCT00105144 - Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Phase 3
Completed NCT03667690 - Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis Phase 3
Completed NCT03604705 - An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia Phase 2
Completed NCT00607763 - Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug Phase 1
Completed NCT00608335 - Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug Phase 1
Recruiting NCT04147975 - Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood
Completed NCT01734525 - Negative Beta Glucan in ICU Patients Phase 4
Withdrawn NCT01622595 - UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients N/A
Completed NCT03363841 - Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) Phase 3
Completed NCT03799172 - Echinocandins Versus Azoles for Candidemia Treatment
Completed NCT01406093 - Early- and Late-onset Candidemia N/A
Completed NCT00670657 - CRITIC - Treatment of Candidemia and Invasive Candidiasis Phase 4
Completed NCT00113191 - Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants N/A