Non-Tuberculous Mycobacterial (NTM) InfectionsNTMdiaryNCT07131774
Treatment Monitoring for NTM Infections With a Symptom Diary
An observational study of Non-Tuberculous Mycobacterial (NTM) Infections, run by Research Center Borstel at 3 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial (NTM) Infections
- What is being tested?
- Filling in a symptom diary
- How many people
- 200 participants
- Where
- 3 sitesGermany
- Study dates
- 11 Jul 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Lack of ability to provide informed consent
- Language barriers that prevent completion of the diary
- Antimicrobial therapy for the NTM infection already initiated
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, 23845
Barbara Kalsdorf, PD Dr. med., +49 4537 188 3510, bkalsdorf@fz-borstel.de
Barbara Kalsdorf, PD Dr. med.
- Not yet recruiting
Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt
Frankfurt am Main, Hesse, 60590
Nils Wetzstein, PD Dr. med., +49 69 63015452, nils.wetzstein@unimedizin-ffm.de
Nils Wetzstein, PD Dr. med.
- Not yet recruiting
Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Dirk Wagner, Prof. Dr. med., +49 761 27077580, dirk.wagner@uniklinik-freiburg.de
Dirk Wagner, Prof. Dr. med.
About this study
Official title: Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)
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).
Read the 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.
- Being tested
- Filling in a symptom diary
- Keywords
- symptom diary, microbiology, radiology
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling in a symptom diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NTM infection, under therapy | Patients who have a pulmonary NTM infection according to ATS/IDSA criteria and are receiving antimicrobial therapy (Cohort 1). Receives: Other: Filling in a symptom diary | |
| 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). Receives: Other: Filling in a symptom diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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)
Measured: 6 months from enrolment
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 6 months from enrolement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start11 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial (NTM) InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Theo Brehm, Research Center Borstel
- Investigators
- Christoph Lange, Prof. Dr. med. Dr. h.c., Study chair, Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131774
- Sponsor's protocol ID
- NTMdiary2025-002
- Acronym
- NTMdiary
- Status last verified
- Aug 2025
- First submitted
- 29 Apr 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)
- ClinicalTrials.gov ID
- NCT07131774
- Acronym / sponsor ID
- NTMdiary / NTMdiary2025-002
- Keywords
- symptom diary, microbiology, radiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTM infection, under therapy | – | Other: Filling in a symptom diaryPatients who have a pulmonary NTM infection according to ATS/IDSA criteria and are receiving antimicrobial therapy (Cohort 1). |
| NTM infection, no therapy | – | Other: Filling in a symptom diaryPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Lack of ability to provide informed consent
- Language barriers that prevent completion of the diary
- Antimicrobial therapy for the NTM infection already initiated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling in a symptom diaryEach 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. | Other | NTM infection, no therapy, NTM infection, under therapy |
Primary outcome
Degree of correlation of the symptom diary with radiology
Time frame: 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
Time frame: 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
Degree of correlation of the symptom diary with microbiology
Time frame: 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 - time to positivity in liquid culture
Degree of correlation of the symptom diary with microbiology
Time frame: 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 - treatment duration until culture conversion (defined as the absence of detectable mycobacteria using the aforementioned methods)
3 secondary outcomes
Degree of correlation between the symptom diary and further treatment monitoring parameters
Time frame: 6 months from enrolement
Degree of correlation between the symptom diary and further treatment monitoring parameters
Time frame: 6 months from enrolement
Degree of correlation between the symptom diary and further treatment monitoring parameters
Time frame: 6 months from enrolement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be shared upon request.
Related trials for Non-Tuberculous Mycobacterial (NTM) Infections
Enrolling by invitationPhase 1
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
Non-Tuberculous Mycobacterial (NTM) Pneumonia, Mycobacterium Abscessus Infection
Not yet recruitingPhase 2
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Lange, Prof. Dr. med. Dr. h.c. study chair
Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacterial (NTM) Infections, run by Research Center Borstel at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Theo Brehm, Dr. med. (+49 4537 188 2905, tbrehm@fz-borstel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of correlation of the symptom diary with radiology (time frame: 6 months from enrolement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.