State of Play of Non-tuberculous Mycobacteria in Alsace

Non-Tuberculous Mycobacteria Clinical Trial

— Mycoba  

Official title:

State of Play of Non-tuberculous Mycobacteria in Alsace: a Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185166
• Other study ID #: 8780
• Status: Recruiting
• Start date: December 5, 2022
• Est. completion date: June 5, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Loïc KASSEGNE, MD
• Phone: 33 3 69 55 01 88
• Email: loic.kassegne[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The aim of the study is to determine the incidence of non-tuberculous mycobacterial infections in the ALSACE region, the proportion of cases in which the infection causes illness, and its evolution over time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 5, 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Mycobacterium Infections
• Non-Tuberculous Mycobacteria

Locations

Country	Name	City	State
France	Service de Pneumologie - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective description of non-tuberculous mycobacteria in Alsace		Through study completion, an average of 6 months