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

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ClinicalTrials.gov Identifier: NCT03312075
Recruitment Status : Not yet recruiting
First Posted : October 17, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.


Condition or disease Intervention/treatment
Cystic Fibrosis Other: Sputum and blood samples

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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022


Group/Cohort Intervention/treatment
cystic fibrosis patients
Sputum and blood samples
Other: Sputum and blood samples
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of patients screened positive for NTM by serology [ Time Frame: 2 years ]
    The number of patients screened positive for NTM by serology with regard of the number of expectorants collected will be evaluated.



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cystic fibrosis patients
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312075


Contacts
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Contact: Geneviève Hery-Arnaud, professor 0298145102 ext +33 Genevieve.Hery-Arnaud@univ-brest.fr

Locations
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France
CHU Amiens Not yet recruiting
Amiens, France, 80054
Contact: Claire Andrejak, Professor    03-22-45-59-03 ext +33    clandrejak@gmail.com   
CHRU Brest Not yet recruiting
Brest, France, 29200
Contact: Geneviève Hery-Arnaud, Professor    0298145102 ext +33    Genevieve.Hery-Arnaud@univ-brest.fr   
CHU Côte de Nacre Not yet recruiting
Caen, France, 14033
Contact: Karine Campbell, MD    02-31-06-46-76 ext +33    campbell-k@chu-caen.fr   
CHIC Créteil Not yet recruiting
Créteil, France, 94000
Contact: Laurence Bassinet, MD    01-57-02-20-80 ext +33    laurence.bassinet@chicreteil.fr   
CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Boubou Camara, MD    04-76-76-58-46 ext +33    BCamara@chu-grenoble.fr   
CHU Lille Not yet recruiting
Lille, France, 59037
Contact: Anne Prevotat, MD       anne.prevotat@chru-lille.fr   
AP-HP Hôpital Cochin Not yet recruiting
Paris, France, 75679
Contact: pierre-Régis Burgel, Professor    01-46-33-82-53 ext +33    pierre-regis.burgel@aphp.fr   
CHU Bordeaux Not yet recruiting
Pessac, France, 33604
Contact: Julie Macey, MD    05-57-62-32-90 ext +33    julie.macey@chu-bordeaux.fr   
Centre de Perharidy Not yet recruiting
Roscoff, France, 29684
Contact: sophie Ramel, MD    02-98-29-39-39 ext +33    sophie.ramel@ildys.org   
CHU Rouen Not yet recruiting
Rouen, France, 76031
Contact: Hélène Morisse-Pradier, MD       helene.morisse-pradier@chu-rouen.fr   
CHR Sud Réunion Not yet recruiting
Saint-Pierre, France, 97410
Contact: Céline Tasset, MD       celine.tasset@chu-reunion.fr   
Sub-Investigator: Annabelle Payet-Charneau, MD         
AP-HP Hôpital Foch Not yet recruiting
Suresnes, France, 92151
Contact: Dominique Grenet, MD    01-46-25-25-82 ext +33    d.grenet@hopital-foch.org   
CHU Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Marlène Murris-Espin, MD    05-67-77-18-51 ext +33    murris.m@chu-toulouse.fr   
CHU Tours Not yet recruiting
Tours, France, 37044
Contact: Julie Mankikian, MD    02-47-47-98-34 ext +33    JMANKIKIAN@chu-tours.fr   
Sponsors and Collaborators
University Hospital, Brest

Publications:

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03312075     History of Changes
Other Study ID Numbers: CIMENT (29BRC17.0001)
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections