Treatment Monitoring for NTM Infections With a Symptom Diary

NCT ID: NCT07131774

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-11
• Study Completion Date: 2026-06-30

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.

Conditions

Non-Tuberculous Mycobacterial (NTM) Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NTM infection, under therapy

Patients who have a pulmonary NTM infection according to ATS/IDSA criteria and are receiving antimicrobial therapy (Cohort 1).

Filling in a symptom diary

Intervention Type: 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

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).

Filling in a symptom diary

Intervention Type: 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.

Interventions

Filling in a symptom diary

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Center Borstel

OTHER

Sponsor Role: lead

Responsible Party

Thomas Theo Brehm

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center

Locations

Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status: NOT_YET_RECRUITING

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

Frankfurt am Main, Hesse, Germany

Site Status: NOT_YET_RECRUITING

Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center

Borstel, Schleswig-Holstein, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Theo Brehm, Dr. med.

Role: CONTACT

tbrehm@fz-borstel.de

+49 4537 188 2905

Niklas Köhler, Dr. med.

Role: CONTACT

nkoehler@fz-borstel.de

+49 4537 188 8080

Facility Contacts

Dirk Wagner, Prof. Dr. med.

Role: primary

dirk.wagner@uniklinik-freiburg.de

+49 761 27077580

Nils Wetzstein, PD Dr. med.

Role: primary

nils.wetzstein@unimedizin-ffm.de

+49 69 63015452

Barbara Kalsdorf, PD Dr. med.

Role: primary

bkalsdorf@fz-borstel.de

+49 4537 188 3510

Other Identifiers

NTMdiary2025-002

Identifier Type: -

Identifier Source: org_study_id