CTRI/2022/04/042124招募中Unknown
A Prospective, Multi-centre, Active Post-Marketing Surveillance Study of Liposomal Amphotericin B (Amphonex® - Manufactured by Bharat serums and Vaccines ltd) in Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy in Real World Clinical Practice (AMBeR)
Bharat Serums and Vaccines Ltd16 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年4月26日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- Incidences of Serious adverse events (SAEs) and adverse events (AEs) which are (serious/non-serious, expected/unexpected, related to the study drug) reported during the study.
研究概览
简要总结
This is a prospective, multicenter, active post-marketing surveillance study for evaluation of the safety of Amphonex® in IFI patients who are refractory to or intolerant of conventional Amphotericin B therapy in real-world clinical practice.
All relevant information on the health condition of the subjects will be collected daily till the subject is discharged from the hospital. All TEAEs will be noted and analyzed.
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
- •Subjects of either gender ≥ 18 years of age.
- •Subjects who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (Amphonex®) treatment as per Investigator’s discretion for current illness.
- •Subjects/LAR willing and able to give written informed consent according to applicable regulatory requirements.
排除标准
- •History of anaphylactic or other severe systemic reaction to Lipid-based amphotericin b or any of its excipients.
- •Subjects suffering from any medical condition that in the investigator’s opinion could compromise the subject’s ability to participate in the clinical study.
- •Subject participating prospectively in another clinical study within the last four weeks before the enrolment to the study.
- •In the last six weeks Subject have taken any amphotericin B preparation other than Amphonex®.
- •Subjects on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus.
- •Pregnant or nursing females.
结局指标
主要结局
Incidences of Serious adverse events (SAEs) and adverse events (AEs) which are (serious/non-serious, expected/unexpected, related to the study drug) reported during the study.
时间窗: Throughout the study
次要结局
- Percentage of subjects with adverse events(Throughout the study)
- Percentage of subjects with treatment discontinuation due to study drug-related adverse events(Throughout the study)
研究者
研究点 (16)
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