Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.


Clinical Trial Description

A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00106288
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 3
Start date January 2003
Completion date December 2005

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 NCT02391532 - Effect of Probiotic Bacteria on Oral Candida in Frail Elderly N/A
Completed NCT01447407 - Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine Phase 1
Not yet recruiting NCT00889356 - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis Phase 3
Completed NCT00105144 - Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Phase 3
Completed NCT00163111 - A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood. Phase 3
Completed NCT00138502 - Funguria in Hospitalized Patients
Not yet recruiting NCT04502277 - Bioavailability of Flucanazole Early Phase 1
Completed NCT03203551 - Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous. N/A
Completed NCT05044156 - Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Completed NCT01322698 - Staging Candidiasis in ICU Patients N/A
Terminated NCT01092832 - A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients Phase 3
Terminated NCT00095316 - Caspofungin Study for Fungal Infections in Adults in Critical Care Settings Phase 3
Completed NCT04122560 - Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration Phase 4
Completed NCT02641717 - Validity of Patient-Collected Wet Mounts N/A
Recruiting NCT01253954 - A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China N/A
Completed NCT00734539 - Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight Phase 3
Completed NCT00797420 - Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers Phase 1
Completed NCT00001937 - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients Phase 3
Completed NCT02666716 - Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients