Non-Tuberculous Mycobacterial (NTM) Infections
Conditions
Keywords
symptom diary, microbiology, radiology
Brief summary
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).
Detailed 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.
Interventions
OTHERFilling in a symptom diary
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.
Sponsors
Research Center Borstel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of correlation of the symptom diary with radiology | 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 | 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 \- the mycobacterial load in sputum microscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of correlation between the symptom diary and further treatment monitoring parameters | 6 months from enrolement | 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). |
Countries
Germany
Contacts
Primary ContactThomas Theo Brehm, Dr. med.
Backup ContactNiklas Köhler, Dr. med.
Outcome results
None listed