Treatment Monitoring for NTM Infections With a Symptom Diary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Center Borstel
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pulmonary NTM infection according to ATS/IDSA criteria (1)
Age ≥ 18 years
Ability to provide informed consent
Willingness to participate in the study AND
Disqualifiers
Lack of ability to provide informed consent
Language barriers that prevent completion of the diary
Antimicrobial therapy for the NTM infection already initiated
Trial population
Patients \> 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Filling in a symptom diary
Other interventionEach 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: NTM infection, under therapy1 intervention
Group B: NTM infection, no therapy1 intervention
Trial outcomes
Primary outcomes
1
Degree of correlation of the symptom diary with radiology
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).
Time frame
6 months from enrolement2
Degree of correlation of the symptom diary with microbiology
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 \- the mycobacterial load in sputum microscopy
Time frame
6 months from enrolment3
Degree of correlation of the symptom diary with microbiology
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 \- time to positivity in liquid culture
Time frame
6 months from enrolment4
Degree of correlation of the symptom diary with microbiology
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)
Time frame
6 months from enrolmentSecondary outcomes
1
Degree of correlation between the symptom diary and further treatment monitoring parameters
Degree of correlation between patient-reported symptoms recorded in the diary and the radiological course of disease in patients with pulmonary infections caused by nontuberculous mycobacteria. 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).
Time frame
6 months from enrolement2
Degree of correlation between the symptom diary and further treatment monitoring parameters
Differences in the severity and development of symptoms during the course of treatment depending on the mycobacterial subspecies.
Time frame
6 months from enrolement3
Degree of correlation between the symptom diary and further treatment monitoring parameters
Degree of correlation between patient-reported symptoms recorded in the diary over the course of the study and the use of antimicrobial therapy.
Time frame
6 months from enrolementSponsors and contacts
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Source ClinicalTrials.gov