Non-Tuberculous Mycobacterial PneumoniaNCT06522347
Mycobacteria Registry Study: Prospective Observational Study in Austria
An observational study of Non-Tuberculous Mycobacterial Pneumonia and Tuberculosis, run by Ludwig Boltzmann Institute for Lung Health at 3 sites in Austria.
Trial summary
The goal of this non-interventional registry study is to systematically collect epidemiological and clinical data throughout the treatment course to learn about effectiveness of treatments. We will document the natural course of therapy without additional interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial Pneumonia, Tuberculosis
- How many people
- 1,000 participants
- Where
- 3 sitesAustria
- Study dates
- 1 Jan 2023to 31 Dec 2053
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient presenting to outpatient clinic or ward of Klink Penzing or Klinik Hietzing due to Mycobacteria infection.
Who may be able to join
- patients diagnosed with Mycobacterium tuberculosis or non-tuberculous mycobacteria infection
- individuals aged 18 years or older
- written informed consent
Who cannot join
- to not comprehend and rightfully judge participation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria3 sites, 3 recruiting
- Recruiting
Klinik Hietzing
Vienna, 1130
Robab Breyer-Kohansal, +431 80110 2472, robab.breyer-kohansal@lunghealth.lbg.ac.at
Carmen Maria Bereuter, +431 80110 2472, carmen.bereuter@gesundheitsverbund.at
- Recruiting
Klinik Penzing
Vienna, 1140
Marie-Kathrin Breyer, +431 91060 42002, marie-kathrin.breyer@lunghealth.lbg.ac.at
Michael Knappik, +431 91060 41420, michael.knappik@gesundheitsverbund.at
- Recruiting
Ludwig Boltzmann Institut for Lung Health
Vienna, 1140
Marie-Kathrin Breyer, +431 91060 42002, marie-kathrin.breyer@lunghealth.lbg.ac.at
Robab Breyer-Kohansal, +431 80110 2472, robab.breyer-kohansal@lunghealth.lbg.ac.at
About this study
The goal of this non-interventional registry study is to systematically collect epidemiological and clinical data throughout the treatment course to learn about effectiveness of treatments. We will document the natural course of therapy without additional interventions. The main question to answer is:
What are the risk factors for mortality due to infection with Mycobacteria tuberculosis (TB) or Nontuberculous mycobacteria (NTM) in Austria?
Data from participants already receiving treatment as part of their regular medical care for TB or NTM infections will be collected.
- Keywords
- Mycobacterium tuberculosis, Nontuberculous Mycobacteria, Mycobacterium Infections
- Medical subject headings
- Tuberculosis, Mycobacterium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality due to tuberculosis or NTM infection in Austria
Measured: 30 years
Secondary outcomes (3)
Prevalence
Prevalence of mycobacterial infections in Austria
Measured: 30 years
Patient cohort
Description of the patient cohort
Measured: 30 years
Risk factors
Identification of risk factors for treatment failure and complications
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2053 (estimated)
- Study completion31 Dec 2053 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Lung Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sigmund Freud PrivatUniversitat
- Responsible party
- Principal investigator, Robab Breyer-Kohansal, Ludwig Boltzmann Institute for Lung Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522347
- Sponsor's protocol ID
- TBC-NTM
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycobacteria Registry Study: Prospective Observational Study in Austria
- ClinicalTrials.gov ID
- NCT06522347
- Acronym / sponsor ID
- TBC-NTM
- Keywords
- Mycobacterium tuberculosis, Nontuberculous Mycobacteria, Mycobacterium Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute for Lung HealthUniversity, hospital or other
- Collaborators
- Sigmund Freud PrivatUniversitat
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2053 (estimated)
- Study completion
- 31 Dec 2053 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this non-interventional registry study is to systematically collect epidemiological and clinical data throughout the treatment course to learn about effectiveness of treatments. We will document the natural course of therapy without additional interventions. The main question to answer is:
What are the risk factors for mortality due to infection with Mycobacteria tuberculosis (TB) or Nontuberculous mycobacteria (NTM) in Austria?
Data from participants already receiving treatment as part of their regular medical care for TB or NTM infections will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient presenting to outpatient clinic or ward of Klink Penzing or Klinik Hietzing due to Mycobacteria infection.
Key inclusion criteria (3 listed)
- patients diagnosed with Mycobacterium tuberculosis or non-tuberculous mycobacteria infection
- individuals aged 18 years or older
- written informed consent
Key exclusion criteria (1 listed)
- to not comprehend and rightfully judge participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 years
Mortality due to tuberculosis or NTM infection in Austria
3 secondary outcomes
Prevalence
Time frame: 30 years
Patient cohort
Time frame: 30 years
Risk factors
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ludwig Boltzmann Institut for Lung Health
Vienna, Austria
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacterial Pneumonia and Tuberculosis, run by Ludwig Boltzmann Institute for Lung Health at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.