Treatment Monitoring for NTM Infections With a Symptom Diary

NCT07131774 | Recruiting

• 1 other identifier: NTMdiary2025-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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).

Conditions

Non-Tuberculous Mycobacterial (NTM) Infections

Keywords

symptom diary; microbiology; radiology

Outcome Measures

Primary Outcomes (4)

• 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)

  6 months from enrolment

Secondary Outcomes (3)

• Degree of correlation between the symptom diary and further treatment monitoring parameters

  6 months from enrolement

• Degree of correlation between the symptom diary and further treatment monitoring parameters

  6 months from enrolement

• Degree of correlation between the symptom diary and further treatment monitoring parameters

  6 months from enrolement

Study Arms (2)

NTM infection, under therapy

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

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).

Other: Filling in a symptom diary

Interventions

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.

NTM infection, no therapy; NTM infection, under therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Lack of ability to provide informed consent
• Language barriers that prevent completion of the diary
• Antimicrobial therapy for the NTM infection already initiated

Sponsors & Collaborators

• Research Center Borstel: lead

Study Sites (3)

Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

NOT YET RECRUITING

Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

NOT YET RECRUITING

Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center

Borstel, Schleswig-Holstein, 23845, Germany

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

• Christoph Lange, Prof. Dr. med. Dr. h.c.

  Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: August 20, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

DE (3)