Micafungin Salvage Mono-therapy in Invasive Aspergillosis
This study has been terminated.
(Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis)
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00376337
First received: September 13, 2006
Last updated: October 18, 2011
Last verified: October 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Invasive Aspergillosis |
Drug: Micafungin Drug: Systemic antifungal therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis |
Resource links provided by NLM:
MedlinePlus related topics:
Aspergillosis
Drug Information available for:
Miconazole nitrate
Miconazole
Clotrimazole
Micafungin sodium
Micafungin
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response. [ Time Frame: Weeks 3-12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall success at end of treatment [ Time Frame: Weeks 3-12 ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | June 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
infusion for 3-12 weeks
|
Drug: Systemic antifungal therapy
IV
|
|
Experimental: 2
infusion for 3-12 weeks
|
Drug: Micafungin
IV
Other Name: FK463
|
Detailed 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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products
Exclusion Criteria:
- Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376337
Show 48 Study Locations
Show 48 Study LocationsSponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Central Contact | Astellas Pharma Europe BV |
More Information
Additional Information:
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00376337 History of Changes |
| Other Study ID Numbers: | FG463-21-20 |
| Study First Received: | September 13, 2006 |
| Last Updated: | October 18, 2011 |
| Health Authority: | European Union: European Medicines Agency Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Belgium: Directorate general for the protection of Public health: Medicines Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: The Italian Medicines Agency Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: Ministry of Health Brazil: National Committee of Ethics in Research Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Croatia: Ministry of Health and Social Care |
Keywords provided by Astellas Pharma Inc:
|
Invasive Aspergillosis Salvage Therapy Micafungin |
Additional relevant MeSH terms:
|
Aspergillosis Mycoses Antifungal Agents Clotrimazole Miconazole Micafungin Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Local 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013