Mycobacteria Registry Study: Prospective Observational Study in Austria

July 22, 2024 updated by: Robab Breyer-Kohansal, Ludwig Boltzmann Institute for Lung Health

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient presenting to outpatient clinic or ward of Klink Penzing or Klinik Hietzing due to Mycobacteria infection.

Description

Inclusion Criteria:

  • patients diagnosed with Mycobacterium tuberculosis or non-tuberculous mycobacteria infection
  • individuals aged 18 years or older
  • written informed consent

Exclusion Criteria:

  • to not comprehend and rightfully judge participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 years
Mortality due to tuberculosis or NTM infection in Austria
30 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence
Time Frame: 30 years
Prevalence of mycobacterial infections in Austria
30 years
Patient cohort
Time Frame: 30 years
Description of the patient cohort
30 years
Risk factors
Time Frame: 30 years
Identification of risk factors for treatment failure and complications
30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute for Lung Health

Collaborators

Sigmund Freud PrivatUniversitat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2053

Study Completion (Estimated)

December 31, 2053

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBC-NTM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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