Clinical Trials Logo
  1. Home
  2. Fungemia
  3. NCT00794703

A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

Fungal Infections Clinical Trial

Official title:
A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant

Clinical Trial Summary

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Clinical Trial Description

Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00794703
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 3
Start date November 2008
Completion date November 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT00177788 - Voriconazole as Prophylaxis for Liver Transplant Recipients N/A
Completed NCT00027248 - Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections Phase 3
Completed NCT01359891 - Clinical Evaluation of Novel Biomarkers in Patients With Septicemia
Completed NCT00001937 - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients Phase 3
Recruiting NCT01260974 - Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients Phase 2
Recruiting NCT04368559 - Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation Phase 3
Completed NCT01236261 - Prospective Population Study on Candidemia in Spain N/A
Active, not recruiting NCT02743585 - Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT) N/A
Completed NCT03876990 - Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia. N/A
Completed NCT02734862 - CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension Phase 2
Completed NCT02719769 - Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture N/A
Completed NCT01450358 - Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture. Phase 4
Completed NCT00841971 - Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients Phase 4
Completed NCT01898208 - Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures N/A
Terminated NCT00806351 - An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System Phase 3
Terminated NCT00805740 - An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida Phase 3
Unknown status NCT00460330 - Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT N/A
Completed NCT00001810 - An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections Phase 3