Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Degree of correlation of the symptom diary with radiology
研究概览
简要总结
The primary aim of the study is to investigate the correlation between patient-reported symptoms recorded in the diary and the microbiological and radiological disease course in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM).
详细描述
This prospective observational study investigates the suitability of a symptom diary for assessing disease progression and treatment outcomes in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM). The aim of the study is to correlate the symptoms documented in the diary with microbiological and radiological parameters to gain a better understanding of the disease course and treatment effects. This may contribute to the development of a simpler and non-invasive tool that could improve patients' quality of life and enable more precise monitoring of disease progression.
This multicenter study plans to enroll 200 adult patients with confirmed pulmonary NTM infections who are capable of providing informed consent. Each patient will document daily symptoms - such as cough, body weight, temperature, and other complaints - in a symptom diary over a period of six months. In addition, clinical routine data, including microbiological and radiological findings, will be used without requiring any additional diagnostic procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary NTM infection according to ATS/IDSA criteria (1)
- •Age ≥ 18 years
- •Ability to provide informed consent
- •Willingness to participate in the study AND
- •Clinical decision to initiate antimicrobial therapy as part of routine care
- •Cohort 1 OR
- •Clinical decision against antimicrobial therapy as part of routine care
排除标准
- •Lack of ability to provide informed consent
- •Language barriers that prevent completion of the diary
- •Antimicrobial therapy for the NTM infection already initiated
结局指标
主要结局
Degree of correlation of the symptom diary with radiology
时间窗: 6 months from enrolement
The primary endpoint of the study is the degree of correlation between patient-reported symptoms recorded in the diary in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM) and the radiological course of the disease. Radiological course of the disease is assessed by a radiological composit measure consisting of an ordinal scale for nodule extent, consolidation extent, bronchiectasis severity and -extent, mucus plugging, cellular bronchiolitis severity and -extent, cavity diameter, -wall thickness, and number of cavities. Worsening (+1, step up) and improvement (-1 step down) are added and show overall worsening (\>= +1), overall improvement (\<= -1) or stable disease (= +/-0).
Degree of correlation of the symptom diary with microbiology
时间窗: 6 months from enrolment
The primary endpoint of the study is the degree of correlation between patient-reported symptoms recorded in the diary in patients with pulmonary infections caused by nontuberculous mycobacteria (NTM) and the microbiological course of the disease, assessed by - treatment duration until culture conversion (defined as the absence of detectable mycobacteria using the aforementioned methods)
次要结局
- Degree of correlation between the symptom diary and further treatment monitoring parameters(6 months from enrolement)
研究者
Thomas Theo Brehm
Dr. med.
Research Center Borstel