Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

Status Completed

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.

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT00105144
Study type	Interventional
Source	Astellas Pharma Inc
Contact
Status	Completed
Phase	Phase 3
Start date	September 2004
Completion date	April 2006

View Details

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	`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	`NCT00797420` - Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers	Phase 1
Completed	`NCT00734539` - Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight	Phase 3
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
Terminated	`NCT00692783` - Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility	N/A