Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07131774

Treatment Monitoring for NTM Infections With a Symptom Diary

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non-Tuberculous Mycobacterial (NTM) Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg, Freiburg im Breisgau, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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)

Secondary outcomes

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

    Time frame: 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).

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

    Time frame: 6 months from enrolement

    Differences in the severity and development of symptoms during the course of treatment depending on the mycobacterial subspecies.

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

    Time frame: 6 months from enrolement

    Degree of correlation between patient-reported symptoms recorded in the diary over the course of the study and the use of antimicrobial therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Niklas Köhler, Dr. med.

CONTACT

[email protected]

+49 4537 188 8080

Thomas Theo Brehm, Dr. med.

CONTACT

[email protected]

+49 4537 188 2905

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Registry information

Official study title

Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)

Acronym: NTMdiary

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.