Micafungin Salvage Mono-therapy in Invasive Aspergillosis

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376337

Enrollment

Registered

2006-09-14

Start date

2006-06-30

Completion date

2008-09-30

Last updated

2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Aspergillosis

Keywords

Invasive Aspergillosis, Salvage Therapy, Micafungin

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)

Interventions

DRUGMicafungin

DRUGSystemic antifungal therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Overall success at end of treatment	Weeks 3-12

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026