Ecology of Nontubercuous MycobacteriaNCT04718571
An Ecological Analysis of Nontuberculous Mycobacteria in the Geneva Area (2015-2020)
An observational study of Ecology of Nontubercuous Mycobacteria and Geneva Area, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Prevalence of NTM diseases has been increasing regularly over the past 30 years in industrialized countries Although NTM are identified worldwide, there are important geographical disparities as to the relative prevalence of NTM species There are no data covering the ecology of NTM in Switzerland. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ecology of Nontubercuous Mycobacteria, Geneva Area
- How many people
- 231 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2020to 1 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with positive clinical samples for nontuberculous mycobacteria (NTM)
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nontuberculous Mycobacteria Identified in Clinical Samples in the Geneva Area Over a Period 2015-2020
Prevalence of NTM diseases has been increasing regularly over the past 30 years in industrialized countries Although NTM are identified worldwide, there are important geographical disparities as to the relative prevalence of NTM species There are no data covering the ecology of NTM in Switzerland. Because of the progressive increase in NTM clinical cases in area Geneva(as noted in other industrialized countries), reporting the specific NTM distribution is important and relevant. In this study, the investigators aimed to: 1/ describe the relative prevalence of NTM species in clinical samples analyzed in the Geneva area, covering ca 500'000 inhabitants over a 5-year period; 2/ determine how many culture positive patients were treated; and 3/ specify the clinical sites involved.
Read the detailed description
This study was performed in the Geneva University Hospitals (HUG), a 2008-bed complex providing care for a population of ca. 500'000 inhabitants. All clinical samples sent for microbiological analysis within HUG are treated by the Bacteriology Laboratory of Geneva University Hospitals. An online database is kept up-to-date and includes all samples processed by the laboratory. The investigators performed a comprehensive analysis of all clinical samples included in this database over a 5-year period (2015-2020). This report focuses only on positive results for nontuberculous mycobacteria (NTM).The following items were recorded: age, gender, BMI whenever available, site of infection (when pulmonary: description of main radiological abnormalities), presence and type of immunosuppression, relevant pulmonary and non-pulmonary comorbidities, results of microscopy, and NTM species identified. The investigators also recorded whether the patient was treated for the identified NTM or not and if a susceptibility profile had been determined (this is not routinely performed and must be requested by the clinician).
The study protocol was approved by their local ethics committee
- Conditions
- Ecology of Nontubercuous Mycobacteria, Geneva Area
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify nontuberculous mycobacteria species
Results of microscopy (positive or negative smear examination), and NTM species were identified (Rapidly or slow growing mycobacteria)
Measured: 2015-2020
Secondary outcomes (5)
Baseline characteristics of patients
Age (in years),
Measured: 2015-2020
Baseline characteristics of patients
gender
Measured: 2015-2020
Baseline characteristics of patients
BMI (in kg/m2)
Measured: 2015-2020
Baseline characteristics of patients
site of infection (pulmonary or extrapulmonary)
Measured: 2015-2020
Baseline characteristics of patients
presence and type of immunosuppression( HIV co-infection, chemotherapy, glucocorticoids)
Measured: 2015-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Aug 2020
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ecology of Nontubercuous MycobacteriaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Janssens, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718571
- Sponsor's protocol ID
- 2020-00872
- Status last verified
- Jan 2021
- First submitted
- 20 Dec 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nontuberculous Mycobacteria Identified in Clinical Samples in the Geneva Area Over a Period 2015-2020
- ClinicalTrials.gov ID
- NCT04718571
- Acronym / sponsor ID
- 2020-00872
- Conditions
- Ecology of Nontubercuous Mycobacteria, Geneva Area
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Jan 2021 (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.
Prevalence of NTM diseases has been increasing regularly over the past 30 years in industrialized countries Although NTM are identified worldwide, there are important geographical disparities as to the relative prevalence of NTM species There are no data covering the ecology of NTM in Switzerland. Because of the progressive increase in NTM clinical cases in area Geneva(as noted in other industrialized countries), reporting the specific NTM distribution is important and relevant. In this study, the investigators aimed to: 1/ describe the relative prevalence of NTM species in clinical samples analyzed in the Geneva area, covering ca 500'000 inhabitants over a 5-year period; 2/ determine how many culture positive patients were treated; and 3/ specify the clinical sites involved.
Detailed description
This study was performed in the Geneva University Hospitals (HUG), a 2008-bed complex providing care for a population of ca. 500'000 inhabitants. All clinical samples sent for microbiological analysis within HUG are treated by the Bacteriology Laboratory of Geneva University Hospitals. An online database is kept up-to-date and includes all samples processed by the laboratory. The investigators performed a comprehensive analysis of all clinical samples included in this database over a 5-year period (2015-2020). This report focuses only on positive results for nontuberculous mycobacteria (NTM).The following items were recorded: age, gender, BMI whenever available, site of infection (when pulmonary: description of main radiological abnormalities), presence and type of immunosuppression, relevant pulmonary and non-pulmonary comorbidities, results of microscopy, and NTM species identified. The investigators also recorded whether the patient was treated for the identified NTM or not and if a susceptibility profile had been determined (this is not routinely performed and must be requested by the clinician).
The study protocol was approved by their local ethics committee
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with positive clinical samples for nontuberculous mycobacteria (NTM)
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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
Identify nontuberculous mycobacteria species
Time frame: 2015-2020
Results of microscopy (positive or negative smear examination), and NTM species were identified (Rapidly or slow growing mycobacteria)
5 secondary outcomes
Baseline characteristics of patients
Time frame: 2015-2020
Baseline characteristics of patients
Time frame: 2015-2020
Baseline characteristics of patients
Time frame: 2015-2020
Baseline characteristics of patients
Time frame: 2015-2020
Baseline characteristics of patients
Time frame: 2015-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ecology of Nontubercuous Mycobacteria and Geneva Area, run by University Hospital, Geneva at 1 site in Switzerland.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jan 2021. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify nontuberculous mycobacteria species (time frame: 2015-2020). 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 22 Jan 2021.