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RECRUITINGOBSERVATIONAL

Treatment Monitoring for NTM Infections With a Symptom Diary

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Pulmonary NTM infection according to ATS/IDSA criteria (1) - Age ≥ 18 years - Ability to provide willing to sign a consent form - 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 Should NOT Join This Trial: - Lack of ability to provide willing to sign a consent form - Language barriers that prevent completion of the diary - Antimicrobial therapy for the NTM infection already initiated Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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.

Locations (3)

Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitätsmedizin Frankfurt
Frankfurt am Main, Hesse, Germany
Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, Germany