Treatment Monitoring for NTM Infections With a Symptom Diary

Recruiting

• Conditions: Non-Tuberculous Mycobacterial (NTM) Infections

• Registration Number: NCT07131774
• Lead Sponsor: Research Center Borstel

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).

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 Timeline

• Study First Submitted: 2025-04-29
• Study Start: 2025-07-11
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of correlation of the symptom diary with radiology	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	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 Outcome Measures

Name	Time	Method
Degree of correlation between the symptom diary and further treatment monitoring parameters	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.

Trial Locations

Locations (3)

Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center; 🇩🇪 Borstel, Schleswig-Holstein, Germany