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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
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)
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Micafungin, Systemic antifungal therapy
Astellas Pharma Inc
Published on BioPortfolio: 2014-07-23T21:35:20-0400
The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy...
The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
Invasive aspergillosis is a type of fungal infection typically identified in very sick patients (for example, patients with cancer or who have had a bone marrow or organ transplant). This...
This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal ag...
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
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Voriconazole is a broad-spectrum antifungal agent commonly used to treat invasive fungal infections (IFI), including aspergillosis, candidiasis, Scedosporium infection, and Fusarium infection. IFI oft...
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Lung infections with the invasive forms of ASPERGILLUS, usually after surgery, transplantation, prolonged NEUTROPENIA or treatment with high-doses of CORTICOSTEROIDS. Invasive pulmonary aspergillosis can progress to CHRONIC NECROTIZING PULMONARY ASPERGILLOSIS or hematogenous spread to other organs.
Infections of the respiratory tract with fungi of the genus ASPERGILLUS. Infections may result in allergic reaction (ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS), colonization in pulmonary cavities as fungus balls (MYCETOMA), or lead to invasion of the lung parenchyma (INVASIVE PULMONARY ASPERGILLOSIS).
One of the triazole ANTIFUNGAL AGENTS that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ERGOSTEROL synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.
The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.
Diagnostic and therapeutic procedures that are invasive or surgical in nature, and require the expertise of a specially trained radiologist. In general, they are more invasive than diagnostic imaging but less invasive than major surgery. They often involve catheterization, fluoroscopy, or computed tomography. Some examples include percutaneous transhepatic cholangiography, percutaneous transthoracic biopsy, balloon angioplasty, and arterial embolization.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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