Overview
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).
Description
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.
Eligibility
Inclusion Criteria:
- 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
- Cohort 2
Exclusion Criteria:
- Lack of ability to provide informed consent
- Language barriers that prevent completion of the diary
- Antimicrobial therapy for the NTM infection already initiated