Mycobacteria Registry Study: Prospective Observational St... | NCT06522347

Studies
Mycobacteria Registry Study: Prospective Observational Study in Austria

NCT06522347

Sponsor

Ludwig Boltzmann Institute for Lung Health

Status

Recruiting

Last Update Posted

Jul 26, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Non-Tuberculous Mycobacterial Pneumonia
Tuberculosis

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2053Estimated

Completion Date

Dec 31, 2053Estimated

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Jul 22, 2024

First Posted Date

Jul 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robab Breyer-Kohansal, Prim.a Priv.-Doz.in Dr.in, Ludwig Boltzmann Institute for Lung HealthPrincipal Investigator

Lead Sponsor

Ludwig Boltzmann Institute for Lung HealthOTHER

Collaborators

Name	Class
Sigmund Freud PrivatUniversitat	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Prevalence	Prevalence of mycobacterial infections in Austria	30 years
Patient cohort	Description of the patient cohort	30 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Hietzing	Recruiting	Vienna		1130	Austria

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections

Ancestor Terms

ID	Term
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided