Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Invasive Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00376337
• Other study ID #: FG463-21-20
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2006
• Last updated: September 4, 2013
• Start date: June 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

Drug:
• Micafungin
IV
• Systemic antifungal therapy
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Colombia,  Croatia,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall success at end of treatment		Weeks 3-12

External Links

•   Link to FDA website
•   Link to Results on JAPIC