RecruitingNCT07131774

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)


Sponsor

Research Center Borstel

Enrollment

200 participants

Start Date

Jul 11, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria3

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

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Interventions

OTHERFilling 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

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NCT07131774