State of Play of Non-tuberculous Mycobacteria in Alsace (Mycoba)

December 14, 2023 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Pneumologie - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Loïc KASSEGNE, MD

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

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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
Time Frame
Retrospective description of non-tuberculous mycobacteria in Alsace
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

December 5, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 5, 2024

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8780

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.

Clinical Trials on Non-Tuberculous Mycobacteria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe