CTRI/2022/08/044680招募中Unknown
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
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- 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)
研究概览
简要总结
A post marketing surveillance study to assess safety and tolerability of Liposomal Amphotericin B Injection (GUFISOME) in patients with Invasive Fungal Infection.
Total 250 subjects will be enrolled in the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/female patients aged ≥ 18 years at the time of consent.
- •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.)
- •Patients who are either treatment naive to Liposomal Amphotericin B or for the current Invasive Fungal Infection episode.
- •Patients who are willing to give voluntary written informed consent.
排除标准
- •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.
结局指标
主要结局
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)
时间窗: Visit 1 baseline and at Visit 2 post-treatment
次要结局
- Percentage of patients with adverse events.(Visit 1 baseline and Visit3 End of study day 28)
- Resolution of fever at the end of treatment, “resolution of feverâ€, defined as the axillary temperature, at the end of treatment, of ≤37°C with a decrease of ≥ 1°C from the initial body temperature(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])
- Treatment discontinuation rates Early discontinuation, discontinuation due to adverse events(Visit 1 basline to visit 2 post treatment)
- Percentage of patients who are tolerable to Liposomal Amphotericin B.(at Visit 2 post-treatment)
研究者
研究点 (8)
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