Micafungin Salvage Mono-Therapy in Invasive Aspergillosis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Aspergillosis
Intervention: Micafungin (Drug); Systemic antifungal therapy (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma Europe BV
Overall contact:
Clinical Research, Phone: +31 71 54 55 878
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 Apsergillosis
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Clinical Research, Phone: +31 71 54 55 878
Rosario, Argentina; Withdrawn
La Plata, Argentina; Recruiting
Buenos Aires, Argentina; Recruiting
Leuven 3000, Belgium; Recruiting
Aalst 9300, Belgium; Not yet recruiting
Bruxelles, Belgium; Recruiting
Gent, Belgium; Recruiting
Sao Paulo, Brazil; Recruiting
Curitiba, Brazil; Recruiting
Belo Horizonte, Brazil; Recruiting
Rio de Janeiro, Brazil; Recruiting
Campinas, Brazil; Withdrawn
Porto Alegre, Brazil; Recruiting
Goiania, Brazil; Recruiting
Santo Andre, Brazil; Recruiting
Campinas, Brazil; Recruiting
Ribeirao Preto, Brazil; Recruiting
Ipatinga, Brazil; Recruiting
Sao Paolo, Brazil; Recruiting
Bogota, Colombia; Recruiting
Cali, Colombia; Recruiting
Bucaramanga, Colombia; Recruiting
Zagreb, Croatia; Withdrawn
Rijeka, Croatia; Recruiting
Zagreb, Croatia; Recruiting
Olomouc 77520, Czech Republic; Recruiting
Praha 12820, Czech Republic; Recruiting
Praha, Czech Republic; Recruiting
Hradec Kralove, Czech Republic; Recruiting
Dijon 21034, France; Recruiting
Lyon Cedex 3, France; Withdrawn
Dijon, France; Recruiting
Paris Cedex 10, France; Recruiting
Pessac Cedex, France; Recruiting
Paris Cedex, France; Recruiting
Nantes, France; Withdrawn
Bobigny, France; Recruiting
Besancon, France; Withdrawn
Munster, Germany; Recruiting
Berlin, Germany; Recruiting
Bonn, Germany; Recruiting
Bielefeld, Germany; Withdrawn
Wuerzburg, Germany; Recruiting
Munich, Germany; Recruiting
Budapest, Hungary; Recruiting
Pavia, Italy; Recruiting
Monza, Italy; Recruiting
Rozzano, Italy; Recruiting
Lodz, Poland; Recruiting
Krakow, Poland; Recruiting
Poznan, Poland; Recruiting
Barcelona 08036, Spain; Withdrawn
Madrid 28034, Spain; Recruiting
Madrid 28046, Spain; Recruiting
Sevilla, Spain; Recruiting
Madrid, Spain; Withdrawn
Salamanca, Spain; Recruiting
Additional Information
Link to FDA website
Starting date: June 2006
Ending date: December 2009
Last updated: August 20, 2008
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