Status:
TERMINATED
Micafungin Salvage Mono-therapy in Invasive Aspergillosis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Invasive Aspergillosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00376337
Start Date
June 1 2006
End Date
September 1 2008
Last Update
September 5 2013
Active Locations (46)
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1
Buenos Aires, Argentina
2
La Plata, Argentina
3
Aalst, Belgium, 9300
4
Brussels, Belgium