An Open Label Study To Evaluate The Safety And Efficacy Of Amphotericin B Lipid Suspension For Injection (AmfyÂ®) in Immunocompromised patients with Invasive Fungal Infections (IFI)

Intas Pharmaceutical Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Able to give written informed consent (the patient or LAR) for participation in the trial.
•Patients with â??probableâ?? or â??provenâ?? IFI established by the European
•Organization for Research and Treatment of Cancer (EORTC)/ Mycosis Study
•Group (MSG) 8. Patients with â??possibleâ?? IFI, will be allowed to enroll in the study, however, â??probableâ?? or â??provenâ?? diagnosis must be established within 4 working days of enrollment to adjust the study drug dosing during the trial.
•Able to comply with study procedures, in the opinion of the investigator
•Patients diagnosed with probable invasive fungal infections should satisfy following criteria:
•a)Atleast one of the following Host factors i.e.
•Recent history of neutropenia (Neutropenia is defined by a neutrophil
•count of less than 500 per cubic millimeter at some point during the
•previous two weeks) temporally related to the onset of fungal disease
•Receipt of an allogeneic stem cell transplant
•Prolonged use of corticosteroids (excluding among patients with
•allergic bronchopulmonary aspergillosis) at a mean minimum dose of
•0.3 mg/kg/day of prednisone equivalent for >3 weeks
•Treatment with other recognized T cell immunosuppressants, such as cyclosporine, TNF-a blockers, specific monoclonal antibodies (such as
•alemtuzumab), or nucleoside analogues during the past 90 days
•Inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency)

•Known allergy or hypersensitivity to Amphotericin B or lipid based formulations of Amphotericin B.
•Patient with endemic mycoses. (histoplasmosis, blastomycosis, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis, and infection due to Penicillium marneffei).
•Patients who requires anticipated duration of antifungal treatment more than 12 weeks and /or surgery for the fungal infection
•Patient who has already received any Amphotericin B within14 days prior to dosing.
•Female patient who is pregnant or lactating

发起方

Intas Pharmaceutical Ltd