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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTM infection, under therapy | Patients who have a pulmonary NTM infection according to ATS/IDSA criteria and are receiving antimicrobial therapy (Cohort 1). |
| |
| NTM infection, no therapy | Patients who have a pulmonary NTM infection according to ATS/IDSA criteria but are not receiving therapy due to a clinical decision or the patient's own choice (Cohort 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filling in a symptom diary | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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
Clinical decision against antimicrobial therapy as part of routine care
Exclusion Criteria:
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Patients > 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Theo Brehm, Dr. med. | Contact | +49 4537 188 2905 | tbrehm@fz-borstel.de | |
| Niklas Köhler, Dr. med. | Contact | +49 4537 188 8080 | nkoehler@fz-borstel.de |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Lange, Prof. Dr. med. Dr. h.c. | Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg | Not yet recruiting | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
Data will be shared upon request.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| 6 months from enrolment |
| 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. | 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. | 6 months from enrolement |
| Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt | Not yet recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
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| Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center | Recruiting | Borstel | Schleswig-Holstein | 23845 | Germany |
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