Clinical trial NCT00376337: Micafungin Salvage Mono-therapy in Invasive Aspergillosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Invasive Aspergillosis
Keywords: Invasive Aspergillosis
Salvage Therapy
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.
timeFrame: Weeks 3-12
Secondary outcomes:
measure: Overall success at end of treatment
timeFrame: Weeks 3-12
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Aalst
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Belo Horizonte
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Ipatinga
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirao Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Santo Andre
country: Brazil
city: Sao Paolo
country: Brazil
city: Sao Paulo
country: Brazil
city: Bogota
country: Colombia
city: Bucaramanga
country: Colombia
city: Cali
country: Colombia
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Bobigny
country: France
city: Dijon
country: France
city: Dijon
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex
country: France
city: Pessac Cedex
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Munich
country: Germany
city: Munster
country: Germany
city: Wuerzburg
country: Germany
city: Budapest
country: Hungary
city: Monza
country: Italy
city: Pavia
country: Italy
city: Rozzano
country: Italy
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_DIRECTOR
References: