Health Condition 1: B35-B49- Mycoses
Conditions
Interventions
Intervention1: Liposomal Amphotericine B: GUFISOME (Liposomal Amphotericin B)
Composition:
Each Vial contains:
Amphotericin I.P:50 mg
Dosage form and strength:
Gufisome is supplied in glass vials cont
Sponsors
Gufic Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/female patients aged = 18 years at the time of consent. 2. Patients with clinical and mycological diagnosis of Invasive Fungal Infection, who are refractory to or intolerant of conventional Amphotericin B therapy. 3 Confirmed invasive fungal infection by the presence of moulds or yeasts in a deep tissue biopsy or a culture obtained by a sterile procedure (Mucormycosis, Aspergillus, Candida, Pneumocystis and Cryptococcus spp.) 4. Patients who are either treatment naive to Liposomal Amphotericin B or for the current Invasive Fungal Infection episode. 5. Patients who are willing to give voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with Life expectancy below 72 hours. 2.Patients with known history of hypersensitivity to Liposomal Amphotericin B or any of its components. 3.Patients with any other condition, in the opinion of the investigator, which would affect the safety of the patient if Liposomal Amphotericin B is administered. 4.Patients with history of intolerance to Amphotericin B. 5.Patients with Clinically significant screening laboratory parameters in the opinion of the investigator ((Eg.Hemoglobin of >5 g/dL,serum creatinine >2mg/dL or creatinine clearance 5 UNL). 6.History of uncontrolled diseases, such as DM, hypertension; clinically significant Hematopoietic, renal, hepatic, electrolyte disorders, thyroidal dysfunction, angina pectoralis, serious cardiac arrhythmias, serious heart failure, neuropsychiatric infection, immunocompromised or any other disease in the opinion of the investigator. 7.Female patients who are breast-feeding/ pregnant, or intends to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All Treatment emergent Adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related).(Time Frame at Visit 1/baseline & at Visit 2/post-treatment)Timepoint: Visit 1 baseline and at Visit 2 post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with adverse events.Timepoint: Visit 1 baseline and Visit3 End of study day 28;Treatment discontinuation rates Early discontinuation, discontinuation due to adverse eventsTimepoint: Visit 1 basline to visit 2 post treatment;Resolution of fever at the end of treatment, “resolution of fever ?, defined as the axillary temperature, at the end of treatment, of =37°C with a decrease of = 1°C from the initial body temperatureTimepoint: Visit 1 baseline and at Visit 2 post-treatment;Overall clinical response rate to treatment defined as a) Mycological eradication post-treatment. [Time Frame: at Visit 1/Screening & at Visit 2/Post-treatment] b) Clinical cure or improvement of clinical signs and symptoms post-treatment. [Time Frame: at Visit 1/Baseline & Visit 2/Post-treatment]Timepoint: Visit 1 baseline and at Visit 2 post-treatment;Percentage of patients who are tolerable to Liposomal Amphotericin B.Timepoint: at Visit 2 post-treatment | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Gufic Biosciences Limited
Outcome results
None listed