An observational, practice based, open label, prospective, non-comparative, multicenter, post marketing surveillance to assess safety and tolerability of Liposomal Amphotericin B (Phosome) 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
- 发起方
- Cipla Ltd
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- Safety Endpoints
研究概览
简要总结
This is an observational, practice based, open label, multicenter, post marketing surveillance study. This study is to assess the safety and tolerability of Liposomal Amphotericin B (Phosome – a Cipla Ltd. product) in patients with Invasive Fungal Infection who are refractory to or intolerant of conventional Amphotericin B therapy.Patients who are hospitalized with a confirmed (culture and sensitive to Liposomal Amphotericin B) Invasive Fungal Infection (IFI) will be enrolled into this study. The study treatment and study duration will be at the investigators discretion.Each patient will participate in this study for about 2 weeks. The study duration may extend based on the treatment period required by the patient at the discretion of the investigator. Patients who require anticipated duration of antifungal treatment more than 12 weeks and /or surgery for the fungal infection will not be enrolled into 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
- •1.Written signed and dated informed consent (patient or LAR).
- •2.Either gender with age ≥18 years.
- •3.Patients with Invasive Fungal Infection (IFI) who are refractory to or intolerant of conventional Amphotericin B therapy, as per physician’s discretion.
- •4.Culture proven Aspergillus, Candida, Cryptococcus Invasive Fungal Infection (IFI).
- •5.Patients who are either treatment naïve to Liposomal Amphotericin B or have started Liposomal Amphotericin B treatment within 5 days for the current Invasive Fungal Infection episode.
排除标准
- •1.Known hypersensitivity to Liposomal Amphotericin B or any of its components 2.Pregnant or nursing females 3.Any other condition in the opinion of the investigator would affect the safety of the patient if Liposomal Amphotericin B is administered.
结局指标
主要结局
Safety Endpoints
时间窗: During the treatment period.
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related).
时间窗: During the treatment period.
2.Percentage of patients with adverse events.
时间窗: During the treatment period.
3.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events.
时间窗: During the treatment period.
次要结局
- Not Applicable(Not Applicable)