CTRI/2024/09/074381尚未招募Unknown
A Prospective, Multi-centre, Active Post-Marketing Surveillance Study of Liposomal Amphotericin B injection 50mg per vial (Lyophilized) TRASPOR (R) Manufactured by Emcure Pharmaceuticals LTD. in Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy in Real World Clinical Practice
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- To evaluate the safety of TRASPOR(R) when administered as a treatment in invasive fungal infection (IFI) in patients who are refractory to or intolerant of conventional amphotericin B therapy.The safety data will be collected till the completion of TRASPOR (R) treatment or till discharge from hospital whichever is earlier.
研究概览
简要总结
The primary purpose of this study is to assess safety and effectiveness of Liposomal Amphotericin B injection 50mg/vial (Lyophilized) TRASPOR®, Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Male and non- pregnant, non-lactating female patients of age ≥ 18 years of age.
- •â€¢ Patients who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (TRASPOR®) treatment as per Investigator’s discretion for current illness.
- •â€¢ Patients /LAR willing and able to give written informed consent according to applicable regulatory requirements.
排除标准
- •â€¢ History of anaphylactic or other severe systemic reaction to Lipid based amphotericin B or any of its excipients.
- •â€¢ Patients suffering from any medical condition that in the investigator’s opinion could compromise the patient’s ability to participate in the clinical study.
- •â€¢ Patients participating prospectively in another clinical study within the last four weeks before the enrolment in the study.
- •â€¢ In the last six weeks, patients have taken any amphotericin B preparation other than TRASPOR®.
- •â€¢ Patients on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus.
- •â€¢ Pregnant or lactating females.
结局指标
主要结局
To evaluate the safety of TRASPOR(R) when administered as a treatment in invasive fungal infection (IFI) in patients who are refractory to or intolerant of conventional amphotericin B therapy.The safety data will be collected till the completion of TRASPOR (R) treatment or till discharge from hospital whichever is earlier.
时间窗: The safety data will be collected till the completion of TRASPOR(R) treatment or till discharge from hospital whichever is earlier.
次要结局
- Percentage of patients with adverse event(Percentage of patients with treatment discontinuation due to study drug related adverse events)
研究者
Dr Ketan Shah
Navneet Memorial Hospital
研究点 (5)
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