NCT06522347

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
336mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2023Dec 2053

Study Start

First participant enrolled

January 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
29.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2053

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2053

Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

31 years

First QC Date

July 22, 2024

Last Update Submit

July 22, 2024

Conditions

Non-Tuberculous Mycobacterial PneumoniaTuberculosis

Keywords

Mycobacterium tuberculosisNontuberculous MycobacteriaMycobacterium Infections

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality due to tuberculosis or NTM infection in Austria

    30 years

Secondary Outcomes (3)

  • Prevalence

    30 years

  • Patient cohort

    30 years

  • Risk factors

    30 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • to not comprehend and rightfully judge participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinik Hietzing

Vienna, 1130, Austria

RECRUITING

Klinik Penzing

Vienna, 1140, Austria

RECRUITING

Ludwig Boltzmann Institut for Lung Health

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

TuberculosisMycobacterium Infections

Condition Hierarchy (Ancestors)

Actinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim.a Priv.-Doz.in Dr.in

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2053

Study Completion (Estimated)

December 31, 2053

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations

AU(3)