Micafungin Salvage Mono-therapy in Invasive Aspergillosis
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Aspergillosis
Intervention: Micafungin (Drug); Systemic antifungal therapy (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Central Contact, Study Director, Affiliation: Astellas Pharma Europe B.V.
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 Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.
Secondary outcome: Overall success at end of treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Buenos Aires, Argentina
La Plata, Argentina
Aalst 9300, Belgium
Bruxelles, Belgium
Gent, Belgium
Leuven 3000, Belgium
Belo Horizonte, Brazil
Campinas, Brazil
Curitiba, Brazil
Goiania, Brazil
Ipatinga, Brazil
Porto Alegre, Brazil
Ribeirao Preto, Brazil
Rio de Janeiro, Brazil
Santo Andre, Brazil
Sao Paolo, Brazil
Sao Paulo, Brazil
Bogota, Colombia
Bucaramanga, Colombia
Cali, Colombia
Rijeka, Croatia
Zagreb, Croatia
Hradec Kralove, Czech Republic
Olomouc 77520, Czech Republic
Praha 12820, Czech Republic
Praha, Czech Republic
Bobigny, France
Dijon 21034, France
Dijon, France
Paris Cedex 10, France
Paris Cedex, France
Pessac Cedex, France
Berlin, Germany
Bonn, Germany
Munich, Germany
Munster, Germany
Wuerzburg, Germany
Budapest, Hungary
Monza, Italy
Pavia, Italy
Rozzano, Italy
Krakow, Poland
Lodz, Poland
Poznan, Poland
Madrid 28034, Spain
Madrid 28046, Spain
Salamanca, Spain
Sevilla, Spain
Additional Information
Link to FDA website Link to Results on JAPIC
Starting date: June 2006
Last updated: September 4, 2013
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