Using a daily symptom diary to monitor NTM lung infections
Official title: Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)
Run by Research Center Borstel · NCT07131774 · Data updated 2026-11-12
This project will test whether a daily symptom diary can track disease course in adults with pulmonary nontuberculous mycobacterial (NTM) infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Research Center Borstel Academic / other |
| Locations | 3 sites (Freiburg im Breisgau, Baden-Wurttemberg and 2 other locations) |
| Status | Recruiting |
| Started | July 11, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | August 20, 2025 |
| Trial ID | NCT07131774 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with pulmonary NTM infection by ATS/IDSA criteria who can consent and are willing to complete a daily symptom diary, including those who will start or not start antimicrobials as part of routine care.
✕Probably not a fit
Patients who cannot reliably complete daily diary entries (for example due to language or cognitive barriers), those who have already started antimicrobial therapy for NTM, or those with nonpulmonary NTM disease are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational multicenter study enrolling about 200 adults with confirmed pulmonary NTM infection who can provide informed consent. Participants will record daily symptoms (for example cough, weight, temperature, and other complaints) in a symptom diary for six months while routine microbiological and radiological data from clinical care are collected. The study compares diary entries with microbiology and imaging to see how well patient-reported symptoms reflect objective disease course. No additional diagnostic procedures are required beyond standard clinical care, and participants may be in either a cohort starting antimicrobial therapy or a cohort managed without antimicrobials per clinical decision.
Why it matters
Potential benefit: If successful, this could offer a simple, non-invasive way to monitor NTM lung disease and help guide care while improving patient quality of life.
How similar studies have gone: Symptom diaries and patient-reported outcome measures have been useful in other respiratory diseases, but their specific correlation with microbiological and radiological course in pulmonary NTM infections is relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, Germany Recruiting -
Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany Not yet recruiting -
Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt
Frankfurt am Main, Hesse, Germany Not yet recruiting
Study contacts
- Study coordinator: Thomas Theo Brehm, Dr. med.
- Email: tbrehm@fz-borstel.de
- Phone: +49 4537 188 2905
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.