Non-Tuberculous MycobacteriaMycobaNCT06185166
State of Play of Non-tuberculous Mycobacteria in Alsace
An observational study of Non-Tuberculous Mycobacteria, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacteria
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2022to 5 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult subject (≥ 18 years old) in whom a biological sample is culture positive for a non-tuberculous mycobacterium
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie - CHU de Strasbourg - France
Strasbourg, 67091
Loïc KASSEGNE, MD, 33 3 69 55 01 88, loic.kassegne@chru-strasbourg.fr
Loïc KASSEGNE, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Tuberculous Mycobacteria
- Keywords
- Non-Tuberculous Mycobacteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of non-tuberculous mycobacteria in Alsace
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start5 Dec 2022
- Primary completionJun 2024 (estimated)
- Study completion5 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous MycobacteriaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185166
- Sponsor's protocol ID
- 8780
- Acronym
- Mycoba
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of Play of Non-tuberculous Mycobacteria in Alsace: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06185166
- Acronym / sponsor ID
- Mycoba / 8780
- Conditions
- Non-Tuberculous Mycobacteria
- Keywords
- Non-Tuberculous Mycobacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subject (≥ 18 years old) in whom a biological sample is culture positive for a non-tuberculous mycobacterium
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of non-tuberculous mycobacteria in Alsace
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacteria, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loïc KASSEGNE, MD (33 3 69 55 01 88, loic.kassegne@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of non-tuberculous mycobacteria in Alsace (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.