A post marketing surveillance study to assess safety and tolerability of Liposomal Amphotericin B Injection (GUFISOME) in patients with Invasive Fungal Infection who are refractory to or intolerant of conventional Amphotericin B therapy

Gufic Biosciences Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

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•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.

•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 < 50 mL/min, ALT & AST > 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

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