Bacteriophage Therapy of Difficult-to-treat Infections: a Retrospective, Observational Analysis of the First One Hundred Consecutive Cases Facilitated by a Belgian Consortium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Clinical improvement
研究概览
简要总结
A retrospective, observational analysis of the first one hundred consecutive cases of bacteriophage therapy of difficult-to-treat infections, facilitated by a Belgian consortium.
详细描述
Background: In 2008, the Queen Astrid military hospital (QAMH) re-initiated treatments with phages, in selective cases. The QAMH implemented a Phage Therapy Coordination Center (PTCC), which is an essential step in the re-introduction of safe and efficient phage therapy, in collaboration with several hospitals and the public health authorities.
In 2018, Belgium implemented a pragmatic phage therapy framework that centers on the magistral preparation (compounding pharmacies in the US) of tailor-made phage medicines, which paved the way for a broader and more structured application of phages in Belgium.
The PTCC facilitated phage therapy in about 110 difficult-to-treat infections in patients in Belgium, but also abroad, as the Belgian is increasingly finding appeal in other European countries.
Objective: The goal of this study is to retrospectively analyse observational data on the first one hundred consecutive phage therapy cases of difficult-to-treat infections, which were facilitated by the PTCC. The knowledge gained from these cases would help physicians to select effective treatment protocols and to design new clinical trials.
Study design: A de-identified database consisting of demographical, microbiological and clinical observational data on 100 consecutive phage applications performed between 01/01/2008 and 31/05/22 will be retrospectively analyzed. A list of the parameters that will be analyzed can be found in addendum 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 91 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with difficult-to-treat bacterial infections
排除标准
- 未提供
结局指标
主要结局
Clinical improvement
时间窗: One week to one year after treatment, depending on the infection type
Clinical improvement of at least one symptom associated with the original bacterial infection, as assessed by the treating physician
Microbial eradication
时间窗: One week to one year after treatment, depending on the infection type
The absence of the original causative agent of the bacterial infection in culture
Adverse reactions
时间窗: One week to one year after treatment, depending on the infection type
Duration and severity of adverse reactions, as assessed by the treating physician
次要结局
未报告次要终点
研究者
Sarah Djebara
Internal Medicine and Infectious Diseases Physician
Queen Astrid Military Hospital
