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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

Page last updated: August 23, 2015

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