Health Condition 1: D849- Immunodeficiency, unspecified
Conditions
Interventions
Intervention1: Amphotericin B Lipid Suspension For Injection (Amfy®): Amfy® will be administered by intravenous infusion for 2 hours (+20 minutes).
Control Intervention1: NIL: NIL
Sponsors
Intas Pharmaceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To report the overall response at the end of the study drug treatment regimenTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate at 12 weeks after study entry. Safety of the study drug treatment regimens. Overall clinical response rate at the end of two weeks after the study drug treatment Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactPriyajeet Parekh
NIL
Outcome results
None listed