Micafungin Salvage Mono-therapy in Invasive Aspergillosis - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00376337

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 II

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: FK 463 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

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

Additional Information:

Link to FDA website This link exits the ClinicalTrials.gov site

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 - French Health Products Safety Agency; 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
Micafungin

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012