Micafungin Salvage Mono-therapy in Invasive Aspergillosis

15:00 EDT 2nd September 2014 | BioPortfolio

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)

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Invasive Aspergillosis

Intervention

Micafungin, Systemic antifungal therapy

Location

Buenos Aires
Argentina
9300

Status

Terminated

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Clinical Trials [513 Associated Clinical Trials listed on BioPortfolio]

Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

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.

MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage 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...

A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensi...

A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT

PubMed Articles [14892 Associated PubMed Articles listed on BioPortfolio]

Screening of the central nervous system in children with invasive pulmonary aspergillosis.

The existing guidelines regarding the management of invasive pulmonary aspergillosis do not recommend screening of the extra-pulmonary sites. Due to the fact that the presence of central nervous syste...

Refractory invasive aspergillosis controlled with posaconazole and pulmonary surgery in a patient with chronic granulomatous disease: case report.

Invasive aspergillosis is an important cause of morbidity and mortality in immunocompromised patients. Among primary immunodefiencies, chronic granulomatous disease (CGD) has the highest prevalence of...

Invasive pulmonary aspergillosis post extracorporeal membrane oxygenation support and literature review.

The use of extracorporeal membrane oxygenation (ECMO) for reversible pulmonary failure in critically ill patients has increased over the last few decades. Nosocomial infections are a major complicatio...

Isolated aspergillosis myocardial abscesses in a liver-transplant patient.

Cardiac abscess is an uncommon and fatal complication after transplantation. We report a case of an initially isolated aspergillosis myocardial abscess diagnosed by cardiac magnetic resonance imaging ...

The Impact of New Antifungal Breakpoints on Antifungal Resistance in Candida Species.

We reviewed our antifungal susceptibility data for micafungin, anidulafungin, fluconazole, and voriconazole against Candida species, and compared resistance rates as determined by the previous and rec...

Medical and Biotech [MESH] Definitions

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.

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