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).
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.
Study Type
OBSERVATIONAL
Enrollment
200
Each patient will receive a diary form in which they are asked to record their symptoms, body temperature, and body weight on a daily basis. This approach is intended to provide a comprehensive overview of the disease course and the impact of treatment over time. Depending on hospitalization status, disease severity, treatment progress, and national treatment guidelines, clinical, microbiological, and radiological follow-up assessments will be performed as part of routine care at intervals ranging from weekly to monthly. No additional study visits or microbiological or radiological diagnostics outside of standard clinical care will be conducted.
Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
NOT_YET_RECRUITINGSchwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt
Frankfurt am Main, Hesse, Germany
NOT_YET_RECRUITINGPulmonary Care Center, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, Germany
Degree of correlation of the symptom diary with radiology
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).
Time frame: 6 months from enrolement
Degree of correlation of the symptom diary with microbiology
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 \- the mycobacterial load in sputum microscopy
Time frame: 6 months from enrolment
Degree of correlation of the symptom diary with microbiology
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 \- time to positivity in liquid culture
Time frame: 6 months from enrolment
Degree of correlation of the symptom diary with microbiology
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)
Time frame: 6 months from enrolment
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Degree of correlation between the symptom diary and further treatment monitoring parameters
Degree of correlation between patient-reported symptoms recorded in the diary and the radiological course of disease in patients with pulmonary infections caused by nontuberculous mycobacteria. 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).
Time frame: 6 months from enrolement
Degree of correlation between the symptom diary and further treatment monitoring parameters
Differences in the severity and development of symptoms during the course of treatment depending on the mycobacterial subspecies.
Time frame: 6 months from enrolement
Degree of correlation between the symptom diary and further treatment monitoring parameters
Degree of correlation between patient-reported symptoms recorded in the diary over the course of the study and the use of antimicrobial therapy.
Time frame: 6 months from enrolement