Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Phase 2

Terminated

• Conditions: Invasive Aspergillosis
• Interventions: Drug: Systemic antifungal therapy; Drug: Micafungin

• Registration Number: NCT00376337
• Lead Sponsor: Astellas Pharma Inc

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)

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-14
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-10
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Systemic antifungal therapy	infusion for 3-12 weeks
2	Micafungin	infusion for 3-12 weeks

Primary Outcome Measures

Name	Time	Method
Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.	Weeks 3-12

Secondary Outcome Measures

Name	Time	Method
Overall success at end of treatment	Weeks 3-12