Treatment Monitoring for NTM Infections With a Symptom Diary
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Filling in a symptom diary.
- Who it may be relevant to
- Registry conditions: Non-Tuberculous Mycobacterial (NTM) Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Diary for Assessing Treatment Outcomes in Patients With Pulmonary Infections Caused by Nontuberculous Mycobacteria (NTM)
Overview
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.
Interventions
- 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 rang
Primary outcome measures
- Degree of correlation of the symptom diary with radiology [Time frame: 6 months from enrolement]
- Degree of correlation of the symptom diary with microbiology [Time frame: 6 months from enrolment]
- Degree of correlation of the symptom diary with microbiology [Time frame: 6 months from enrolment]
- Degree of correlation of the symptom diary with microbiology [Time frame: 6 months from enrolment]
Secondary outcome measures (3)
- Degree of correlation between the symptom diary and further treatment monitoring parameters [Time frame: 6 months from enrolement]
- Degree of correlation between the symptom diary and further treatment monitoring parameters [Time frame: 6 months from enrolement]
- Degree of correlation between the symptom diary and further treatment monitoring parameters [Time frame: 6 months from enrolement]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Abteilung Infektiologie, Klinik für Innere Medizin II, Universitätsklinikum Freiburg — Freiburg im Breisgau
- Schwerpunkt Infektiologie, Medizinische Klinik 2, Zentrum für Innere Medizin, Universitäts — Frankfurt am Main
- Pulmonary Care Center, Research Center Borstel, Leibniz Lung Center — Borstel
Identifiers
NCT: NCT07131774 · NTMdiary2025-002