Clinical Trials Logo

Clinical Trial Summary

To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm


Clinical Trial Description

This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study.

Patients will be stratified according to the baseline infection status and the baseline neutropenic status:

- Intolerant to previous antifungal therapy

- Refractory to previous antifungal therapy; progression of infection

- Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory.

- Neutropenic (absolute neutrophil count (ANC < 500 cells/mm3)

- Non neutropenic (ANC >= 500 cells/mm3) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00376337
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 2
Start date June 2006
Completion date September 2008

See also
  Status Clinical Trial Phase
Recruiting NCT06028451 - ManagemEnt of Antifungal Drug in Invasive Aspergillosis:a Real-word Study
Completed NCT00163722 - A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients Phase 3
Completed NCT02394483 - Single Ascending Oral Dose Study of F901318 Phase 1
Completed NCT00404092 - Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis Phase 2
Completed NCT01128907 - Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients N/A
Recruiting NCT01386437 - Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Withdrawn NCT02912026 - Radiolabelled IV and Oral Metabolism Study of F901318 Phase 1
Withdrawn NCT03095547 - Drug/Drug Interactions With F901318 Phase 1
Withdrawn NCT03076905 - Pharmacokinetics of IV Formulation Phase 1
Completed NCT02737371 - Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects Phase 1
Terminated NCT00836875 - A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children Phase 3
Active, not recruiting NCT00838643 - Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) N/A
Terminated NCT04876716 - Azole-echinocandin Combination Therapy for Invasive Aspergillosis Phase 3
Recruiting NCT05101187 - Olorofim Aspergillus Infection Study Phase 3
Enrolling by invitation NCT02104479 - Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
Not yet recruiting NCT05707832 - A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus Phase 3
Recruiting NCT06382922 - Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy
Terminated NCT02396225 - Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration N/A
Recruiting NCT00843804 - Surveillance for Nosocomial Infections in Pediatric Cancer Patients N/A
Completed NCT00334412 - COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis Phase 4