An observational study in Non-Tuberculous Mycobacterial (NTM) Infections, sponsored by Research Center Borstel. Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Research Center Borstel · Observational
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 200 is below the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →Research Center Borstel is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical decision to initiate antimicrobial therapy as part of routine care
Clinical decision against antimicrobial therapy as part of routine care
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have a pulmonary NTM infection according to ATS/IDSA criteria and are receiving antimicrobial therapy (Cohort 1).
Other: Filling in a symptom diary
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).
Other: Filling 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.
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
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
Plan to share: Yes — Data will be shared upon request.
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.
Of 257 non-industry observational studies under Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 11 months is below that.
Counting every sponsor, half of 295 studies reached it within 35 months; a quarter within 18 and three quarters within 67.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Research Center Borstel