Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.

NCT03312075 | Terminated

• 1 other identifier: CIMENT (29BRC17.0001)
• Study Type: observational
• Target: 848
• Locations: 1 country
• Sites: 14

Brief 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. 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Number of patients screened positive for NTM by serology

  2 years

Study Arms (1)

cystic fibrosis patients

Sputum and blood samples

Other: Sputum and blood samples

Interventions

Sputum and blood samples OTHER

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.

cystic fibrosis patients

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cystic fibrosis patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (14)

CHU Amiens

Amiens, Amiens, 80054, France

Location

CHRU Brest

Brest, 29200, France

Location

CHU Côte de Nacre

Caen, 14033, France

Location

CHIC Créteil

Créteil, 94000, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHU Lille

Lille, 59037, France

Location

AP-HP Hôpital Cochin

Paris, 75679, France

Location

CHU Bordeaux

Pessac, 33604, France

Location

Centre de Perharidy

Roscoff, 29684, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHR Sud Réunion

Saint-Pierre, 97410, France

Location

AP-HP Hôpital Foch

Suresnes, 92151, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (8)

• 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.

  PMID: 25178871 BACKGROUND

• Albrecht 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.

  PMID: 26846823 BACKGROUND

• Griffith 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.

  PMID: 17277290 BACKGROUND

• Martiniano 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.

  PMID: 24251858 BACKGROUND

• Floto 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.

  PMID: 26678435 BACKGROUND

• Jeong 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.

  PMID: 23740728 BACKGROUND

• Qvist 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.

  PMID: 26482717 BACKGROUND

• Qvist 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.

  PMID: 25929948 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: March 25, 2019
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (14)