A phase IV study to Evaluate The Safety And Efficacy Of Amphotericin B Lipid Suspension in Immunocompromised patients with Invasive Fungal Infections.
- Conditions
- Health Condition 1: D849- Immunodeficiency, unspecified
- Registration Number
- CTRI/2010/091/003012
- Lead Sponsor
- Intas Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
•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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To report the overall response at the end of the study drug treatment regimenTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Survival rate at 12 weeks after study entry. <br/ ><br>Safety of the study drug treatment regimens. <br/ ><br>Overall clinical response rate at the end of two weeks after the study drug treatment <br/ ><br>Timepoint: 12 weeks