NCT06185166

Brief Summary

Non-tuberculous mycobacteriosis (NTM) are infectious diseases caused by mycobacteria that are not part of the Tuberculosis complex. More than 190 species have been identified to date. As an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. Varying in virulence depending on the species, most infections do not cause illness. There is currently no coordinated care pathway for this pathology in Alsace. The means necessary to set up such a structure requires knowing the importance of the disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

December 14, 2023

Last Update Submit

December 14, 2023

Conditions

Keywords

Non-Tuberculous Mycobacteria

Outcome Measures

Primary Outcomes (1)

  • Retrospective description of non-tuberculous mycobacteria in Alsace

    Through study completion, an average of 6 months

Eligibility Criteria

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

Adult subject (≥ 18 years old) in whom a biological sample is culture positive for a non-tuberculous mycobacterium

You may qualify if:

  • Adult subject (≥ 18 years old)
  • in whom a biological sample is culture positive for a non-tuberculous mycobacterium
  • born in France and domiciled in Alsace (i.e. whose home postal code begins with 67 or 68)
  • not opposing the reuse of its data for scientific research purposes

You may not qualify if:

  • Subject having expressed opposition to participating in the study
  • not domiciled in Alsace
  • Born abroad
  • Isolation of a mycobacterium from the Tuberculosis complex and Mycobacterium gordonae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 29, 2023

Study Start

December 5, 2022

Primary Completion

June 1, 2024

Study Completion

June 5, 2024

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations