Cystic FibrosisCIMENTNCT03312075
Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.
An observational study of Cystic Fibrosis, run by University Hospital, Brest at 14 sites in France.
Trial summary
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sputum and blood samples
- How many people
- 848 participants
- Where
- 14 sitesFrance
- Study dates
- 25 Mar 2019to 24 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cystic fibrosis patients
Who may be able to join
- Patients with a confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
- Affiliation to the social security system
- Patients able to expectorate spontaneously
- Patients enrolled in the French Register of Cystic Fibrosis
- Minor or major patients of expectorant age
- Consent signed by the patient or the holder of parental authority for the children
Who cannot join
- Patient not registered in the French Register of Cystic Fibrosis
- Pulmonary transplant patients
- Persons deprived of liberty, persons under guardianship or curatorship, persons in emergency situations
- Person not affiliated to a social security system or not entitled
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CHU Amiens
Amiens, Amiens, 80054
CHRU Brest
Brest, 29200
CHU Côte de Nacre
Caen, 14033
CHIC Créteil
Créteil, 94000
CHU Grenoble
Grenoble, 38043
CHU Lille
Lille, 59037
AP-HP Hôpital Cochin
Paris, 75679
CHU Bordeaux
Pessac, 33604
Centre de Perharidy
Roscoff, 29684
CHU Rouen
Rouen, 76031
CHR Sud Réunion
Saint-Pierre, 97410
AP-HP Hôpital Foch
Suresnes, 92151
CHU Toulouse
Toulouse, 31059
CHU Tours
Tours, 37044
About this study
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination. The hypothesis is made that these infections are also increasing in France and that dominant NTM clones are circulating. The last French study carried out in 2004 already showed prevalences of up to 10% in certain French regions. It is essential to know the prevalence 8 years later, taking advantage of the new recommendations for the management of patients and samples, which will homogenize practices on French territory.
No data are currently available in France on the prevalence of positive serological responses in cystic fibrosis patients. Serological analyzes of the sera collected during this study will enable us to evaluate the performance of serology in mycobacterial culture and to identify patients with no positive respiratory specimen in culture but with positive serology indicating potential contact with a mycobacterium. The establishment of a serological follow-up of these patients will allow to correlate this result with a clinical evolution and / or the detection of NTM in subsequent samples. Serology is an innovative aspect of the CIMENT study.
Read the detailed description
Non-tuberculous mycobacteria (NTM) are important new pathogens in cystic fibrosis, with prevalence estimates ranging from 6% to 13%. The diagnosis of the disease in cystic fibrosis patients is difficult because the infection may remain indolent in some cases without evidence of clinical consequence, while in other patients NTM are associated with significant morbidity and mortality. Treatment requires antibiotic therapy over a prolonged period (at least 12 to 18 months) with several drugs and varies according to NTM and their antibiotic resistance profile. The development of a specialized approach (clinicians / biologists) in the management of this infection, combined with the diagnosis and treatment of NTM infections, in cystic fibrosis patients is a research priority. It is an indispensable long-term strategy for this high-risk population.
Two main elements confirm the interest of a prevalence survey of NTM infections in cystic fibrosis (CF) patients: the diagnostic difficulty of "true" infections (as opposed to simple colonizations) to NTM, and the clinical impact on respiratory functions of NTM present in these patients. Two recent contradictory studies on the impact of NTM infections in CF patients have recently been published. The German monocentric study suggests a greater deterioration of respiratory function in CF patients not infected with NTM compared to CF patients infected with NTM. 26 patients were infected with NTM: 14/26 with M. avium complex (MAC), 10/26 with M. abscessus complex and 2/26 with M. gordonae. Only 5 patients out of a dozen positive to M. abscessus and 1 in 14 positive to MAC were treated. Comparatively, the other study found a significant deterioration in respiratory function (maximum expired volume in 1 seconde) of CF patients infected with M. abscessus. This Scandinavian national study reinforced its argument by the fact that an effective treatment made it possible to find changes in maximum expired volume in 1 seconde close to that observed before the infection. Some differences are observed in these two studies; including the age of the subjects included, older in the German study, and the number of positive lung samples per patient. The German study retained the criteria of the American Thoracic Society (ATS) / Infectious Disease Society of America (IDSA) for interpreting respiratory specimens positive for MNT. However, these criteria remain very difficult to apply for CF patients because the clinical and radiological manifestations of cystic fibrosis and mycobacterial infection are confounded and other criteria are necessary, such as the number of positive pulmonary samples: 5 vs. 2 to 4 or the decline in maximum expired volume in 1 seconde in the year prior to colonization / MNT infection (-5.8% per year vs. 0.7% per year). We see here the necessity of complementary studies, in order to be able to identify the diagnostic difficulties and the impacts of the therapeutics administered in these patients. Indeed, on the one hand the therapeutic impact is very difficult to evaluate in the face of the very weak correlation between the results of the "antibiograms" and therefore in vitro and the therapeutic effect in vivo. On the other hand, precise diagnostic interpretation remains essential, as published observational studies show real discrepancies, largely due to diagnostic biases. Recently, under the auspices of the American Foundation and the European Cystic Fibrosis Society, guidelines for the management of NTM infections in CF patients have been published. To this is added the references of Microbiology.
Several authors have shown that this diagnosis is an alternative in the context of NTM infections in cystic fibrosis patients. Indeed, as mentioned above, the microbiological diagnosis is often faulted, due to the difficulty of culturing the samples and their low yield in the context of NTM infections. An indirect diagnostic approach can only reinforce the screening of cystic fibrosis patients who have had contact with a NTM. Any serological response, although unable to date an infection, is the result of a potentially protective response of the host undergoing infection, and evidence of antibodies directed against the agent's bacterial products pathogen in circulating blood. A simple colonization does not allow the appearance of antibodies. An infectious process, even inapparent, must have taken place.
- Conditions
- Cystic Fibrosis
- Being tested
- Sputum and blood samples
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum and blood samplesOther
The cystic fibrosis patient will have a first series of sputum as well as a blood sample. On the same day of consultation, a second expectoration will be performed as far as possible.
| Study group | Role | What they receive |
|---|---|---|
| cystic fibrosis patients | Sputum and blood samples Receives: Other: Sputum and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients screened positive for NTM by the culture
The number of patients screened positive for NTM by the culture with regard of the number of expectorants collected will be evaluated.
Measured: 2 years
Secondary outcomes (1)
Number of patients screened positive for NTM by serology
The number of patients screened positive for NTM by serology with regard of the number of expectorants collected will be evaluated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start25 Mar 2019
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: The pace of patient enrollment was significantly affected by the COVID-19 pandemic. Since this is an epidemiological study that does not require a specific number of patients to meet the primary objective, the enrollment period was not extended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312075
- Sponsor's protocol ID
- CIMENT (29BRC17.0001)
- Acronym
- CIMENT
- Status last verified
- Mar 2026
- First submitted
- 12 Oct 2017
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qvist T, Gilljam M, Jonsson B, Taylor-Robinson D, Jensen-Fangel S, Wang M, Svahn A, Kotz K, Hansson L, Hollsing A, Hansen CR, Finstad PL, Pressler T, Hoiby N, Katzenstein TL; Scandinavian Cystic Fibrosis Study Consortium (SCFSC). Epidemiology of nontuberculous mycobacteria among patients with cystic fibrosis in Scandinavia. J Cyst Fibros. 2015 Jan;14(1):46-52. doi: 10.1016/j.jcf.2014.08.002. Epub 2014 Aug 30.
PubMed 25178871Albrecht C, Ringshausen F, Ott S, Wagner D, Rademacher J, Schneider M, Welte T, Pletz MW. Should all adult cystic fibrosis patients with repeated nontuberculous mycobacteria cultures receive specific treatment? A 10-year case-control study. Eur Respir J. 2016 May;47(5):1575-7. doi: 10.1183/13993003.01239-2015. Epub 2016 Feb 4. No abstract available.
PubMed 26846823Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.
PubMed 17277290Martiniano SL, Sontag MK, Daley CL, Nick JA, Sagel SD. Clinical significance of a first positive nontuberculous mycobacteria culture in cystic fibrosis. Ann Am Thorac Soc. 2014 Jan;11(1):36-44. doi: 10.1513/AnnalsATS.201309-310OC.
PubMed 24251858Floto RA, Olivier KN, Saiman L, Daley CL, Herrmann JL, Nick JA, Noone PG, Bilton D, Corris P, Gibson RL, Hempstead SE, Koetz K, Sabadosa KA, Sermet-Gaudelus I, Smyth AR, van Ingen J, Wallace RJ, Winthrop KL, Marshall BC, Haworth CS. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis: executive summary. Thorax. 2016 Jan;71(1):88-90. doi: 10.1136/thoraxjnl-2015-207983.
PubMed 26678435Jeong BH, Kim SY, Jeon K, Lee SY, Shin SJ, Koh WJ. Serodiagnosis of Mycobacterium avium complex and Mycobacterium abscessus complex pulmonary disease by use of IgA antibodies to glycopeptidolipid core antigen. J Clin Microbiol. 2013 Aug;51(8):2747-9. doi: 10.1128/JCM.00702-13. Epub 2013 Jun 5.
PubMed 23740728Qvist T, Taylor-Robinson D, Waldmann E, Olesen HV, Hansen CR, Mathiesen IH, Hoiby N, Katzenstein TL, Smyth RL, Diggle PJ, Pressler T. Comparing the harmful effects of nontuberculous mycobacteria and Gram negative bacteria on lung function in patients with cystic fibrosis. J Cyst Fibros. 2016 May;15(3):380-5. doi: 10.1016/j.jcf.2015.09.007. Epub 2015 Oct 9.
PubMed 26482717Qvist T, Pressler T, Taylor-Robinson D, Katzenstein TL, Hoiby N. Serodiagnosis of Mycobacterium abscessus complex infection in cystic fibrosis. Eur Respir J. 2015 Sep;46(3):707-16. doi: 10.1183/09031936.00011815. Epub 2015 Apr 30.
PubMed 25929948
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.
- ClinicalTrials.gov ID
- NCT03312075
- Acronym / sponsor ID
- CIMENT / CIMENT (29BRC17.0001)
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The pace of patient enrollment was significantly affected by the COVID-19 pandemic. Since this is an epidemiological study that does not require a specific number of patients to meet the primary objective, the enrollment period was not extended.
- Enrolment
- 848 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 17 Oct 2017 (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.
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination. The hypothesis is made that these infections are also increasing in France and that dominant NTM clones are circulating. The last French study carried out in 2004 already showed prevalences of up to 10% in certain French regions. It is essential to know the prevalence 8 years later, taking advantage of the new recommendations for the management of patients and samples, which will homogenize practices on French territory.
No data are currently available in France on the prevalence of positive serological responses in cystic fibrosis patients. Serological analyzes of the sera collected during this study will enable us to evaluate the performance of serology in mycobacterial culture and to identify patients with no positive respiratory specimen in culture but with positive serology indicating potential contact with a mycobacterium. The establishment of a serological follow-up of these patients will allow to correlate this result with a clinical evolution and / or the detection of NTM in subsequent samples. Serology is an innovative aspect of the CIMENT study.
Detailed description
Non-tuberculous mycobacteria (NTM) are important new pathogens in cystic fibrosis, with prevalence estimates ranging from 6% to 13%. The diagnosis of the disease in cystic fibrosis patients is difficult because the infection may remain indolent in some cases without evidence of clinical consequence, while in other patients NTM are associated with significant morbidity and mortality. Treatment requires antibiotic therapy over a prolonged period (at least 12 to 18 months) with several drugs and varies according to NTM and their antibiotic resistance profile. The development of a specialized approach (clinicians / biologists) in the management of this infection, combined with the diagnosis and treatment of NTM infections, in cystic fibrosis patients is a research priority. It is an indispensable long-term strategy for this high-risk population.
Two main elements confirm the interest of a prevalence survey of NTM infections in cystic fibrosis (CF) patients: the diagnostic difficulty of "true" infections (as opposed to simple colonizations) to NTM, and the clinical impact on respiratory functions of NTM present in these patients. Two recent contradictory studies on the impact of NTM infections in CF patients have recently been published. The German monocentric study suggests a greater deterioration of respiratory function in CF patients not infected with NTM compared to CF patients infected with NTM. 26 patients were infected with NTM: 14/26 with M. avium complex (MAC), 10/26 with M. abscessus complex and 2/26 with M. gordonae. Only 5 patients out of a dozen positive to M. abscessus and 1 in 14 positive to MAC were treated. Comparatively, the other study found a significant deterioration in respiratory function (maximum expired volume in 1 seconde) of CF patients infected with M. abscessus. This Scandinavian national study reinforced its argument by the fact that an effective treatment made it possible to find changes in maximum expired volume in 1 seconde close to that observed before the infection. Some differences are observed in these two studies; including the age of the subjects included, older in the German study, and the number of positive lung samples per patient. The German study retained the criteria of the American Thoracic Society (ATS) / Infectious Disease Society of America (IDSA) for interpreting respiratory specimens positive for MNT. However, these criteria remain very difficult to apply for CF patients because the clinical and radiological manifestations of cystic fibrosis and mycobacterial infection are confounded and other criteria are necessary, such as the number of positive pulmonary samples: 5 vs. 2 to 4 or the decline in maximum expired volume in 1 seconde in the year prior to colonization / MNT infection (-5.8% per year vs. 0.7% per year). We see here the necessity of complementary studies, in order to be able to identify the diagnostic difficulties and the impacts of the therapeutics administered in these patients. Indeed, on the one hand the therapeutic impact is very difficult to evaluate in the face of the very weak correlation between the results of the "antibiograms" and therefore in vitro and the therapeutic effect in vivo. On the other hand, precise diagnostic interpretation remains essential, as published observational studies show real discrepancies, largely due to diagnostic biases. Recently, under the auspices of the American Foundation and the European Cystic Fibrosis Society, guidelines for the management of NTM infections in CF patients have been published. To this is added the references of Microbiology.
Several authors have shown that this diagnosis is an alternative in the context of NTM infections in cystic fibrosis patients. Indeed, as mentioned above, the microbiological diagnosis is often faulted, due to the difficulty of culturing the samples and their low yield in the context of NTM infections. An indirect diagnostic approach can only reinforce the screening of cystic fibrosis patients who have had contact with a NTM. Any serological response, although unable to date an infection, is the result of a potentially protective response of the host undergoing infection, and evidence of antibodies directed against the agent's bacterial products pathogen in circulating blood. A simple colonization does not allow the appearance of antibodies. An infectious process, even inapparent, must have taken place.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis patients | – | Other: Sputum and blood samplesSputum and blood samples |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic fibrosis patients
Key inclusion criteria (6 listed)
- Patients with a confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
- Affiliation to the social security system
- Patients able to expectorate spontaneously
- Patients enrolled in the French Register of Cystic Fibrosis
- Minor or major patients of expectorant age
Key exclusion criteria (4 listed)
- Patient not registered in the French Register of Cystic Fibrosis
- Pulmonary transplant patients
- Persons deprived of liberty, persons under guardianship or curatorship, persons in emergency situations
- Person not affiliated to a social security system or not entitled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum and blood samplesThe cystic fibrosis patient will have a first series of sputum as well as a blood sample. On the same day of consultation, a second expectoration will be performed as far as possible. | Other | cystic fibrosis patients |
Primary outcome
Number of patients screened positive for NTM by the culture
Time frame: 2 years
The number of patients screened positive for NTM by the culture with regard of the number of expectorants collected will be evaluated.
1 secondary outcome
Number of patients screened positive for NTM by serology
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The pace of patient enrollment was significantly affected by the COVID-19 pandemic. Since this is an epidemiological study that does not require a specific number of patients to meet the primary objective, the enrollment period was not extended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 25178871Qvist T, Gilljam M, Jonsson B, Taylor-Robinson D, Jensen-Fangel S, Wang M, Svahn A, Kotz K, Hansson L, Hollsing A, Hansen CR, Finstad PL, Pressler T, Hoiby N, Katzenstein TL; Scandinavian Cystic Fibrosis Study Consortium (SCFSC). Epidemiology of nontuberculous mycobacteria among patients with cystic fibrosis in Scandinavia. J Cyst Fibros. 2015 Jan;14(1):46-52. doi: 10.1016/j.jcf.2014.08.002. Epub 2014 Aug 30.
- Background: PubMed 26846823Albrecht C, Ringshausen F, Ott S, Wagner D, Rademacher J, Schneider M, Welte T, Pletz MW. Should all adult cystic fibrosis patients with repeated nontuberculous mycobacteria cultures receive specific treatment? A 10-year case-control study. Eur Respir J. 2016 May;47(5):1575-7. doi: 10.1183/13993003.01239-2015. Epub 2016 Feb 4. No abstract available.
- Background: PubMed 17277290Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.
- Background: PubMed 24251858Martiniano SL, Sontag MK, Daley CL, Nick JA, Sagel SD. Clinical significance of a first positive nontuberculous mycobacteria culture in cystic fibrosis. Ann Am Thorac Soc. 2014 Jan;11(1):36-44. doi: 10.1513/AnnalsATS.201309-310OC.
- Background: PubMed 26678435Floto RA, Olivier KN, Saiman L, Daley CL, Herrmann JL, Nick JA, Noone PG, Bilton D, Corris P, Gibson RL, Hempstead SE, Koetz K, Sabadosa KA, Sermet-Gaudelus I, Smyth AR, van Ingen J, Wallace RJ, Winthrop KL, Marshall BC, Haworth CS. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis: executive summary. Thorax. 2016 Jan;71(1):88-90. doi: 10.1136/thoraxjnl-2015-207983.
- Background: PubMed 23740728Jeong BH, Kim SY, Jeon K, Lee SY, Shin SJ, Koh WJ. Serodiagnosis of Mycobacterium avium complex and Mycobacterium abscessus complex pulmonary disease by use of IgA antibodies to glycopeptidolipid core antigen. J Clin Microbiol. 2013 Aug;51(8):2747-9. doi: 10.1128/JCM.00702-13. Epub 2013 Jun 5.
- Background: PubMed 26482717Qvist T, Taylor-Robinson D, Waldmann E, Olesen HV, Hansen CR, Mathiesen IH, Hoiby N, Katzenstein TL, Smyth RL, Diggle PJ, Pressler T. Comparing the harmful effects of nontuberculous mycobacteria and Gram negative bacteria on lung function in patients with cystic fibrosis. J Cyst Fibros. 2016 May;15(3):380-5. doi: 10.1016/j.jcf.2015.09.007. Epub 2015 Oct 9.
- Background: PubMed 25929948Qvist T, Pressler T, Taylor-Robinson D, Katzenstein TL, Hoiby N. Serodiagnosis of Mycobacterium abscessus complex infection in cystic fibrosis. Eur Respir J. 2015 Sep;46(3):707-16. doi: 10.1183/09031936.00011815. Epub 2015 Apr 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Brest at 14 sites 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 6 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: stopped early, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The study was stopped early (reason given: The pace of patient enrollment was significantly affected by the COVID-19 pandemic. Since this is an epidemiological study that does not require a specific number of patients to meet the primary objective, the enrollment period was not extended.). Results are not available in the source record.
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?
Number of patients screened positive for NTM by the culture (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312075, which also lists 8 linked publications.
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 20 Mar 2026.