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临床试验/NCT05498363
NCT05498363已完成不适用

Bacteriophage Therapy of Difficult-to-treat Infections: a Retrospective, Observational Analysis of the First One Hundred Consecutive Cases Facilitated by a Belgian Consortium

Queen Astrid Military Hospital0 个研究点目标入组 100 人开始时间: 2008年1月1日最近更新:
适应症

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

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

发起方
Queen Astrid Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Djebara

Internal Medicine and Infectious Diseases Physician

Queen Astrid Military Hospital

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