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NCT03312075Terminated

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

Source: ClinicalTrials.gov · Last updated 20 Mar 2026

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.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Observational
Enrollment
848 (actual)
First submitted
12 Oct 2017
Start date
25 Mar 2019
Primary completion date
24 Jun 2024
Lead sponsor
University Hospital, Brest
NCT number
NCT03312075

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pulmonary transplant patients

Other

  • Patient not registered in the French Register of Cystic Fibrosis
  • Persons deprived of liberty, persons under guardianship or curatorship, persons in emergency situations
  • Person not affiliated to a social security system or not entitled

Who the study is looking for

  • 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

Age in the registry: 7 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHU AmiensAmiensFranceUnknown status
CHRU BrestBrestFranceUnknown status
CHU Côte de NacreCaenFranceUnknown status
CHIC CréteilCréteilFranceUnknown status
Chu GrenobleGrenobleFranceUnknown status
CHU LilleLilleFranceUnknown status
AP-HP Hôpital CochinParisFranceUnknown status
CHU BordeauxPessacFranceUnknown status
Centre de PerharidyRoscoffFranceUnknown status
CHU RouenRouenFranceUnknown status
CHR Sud RéunionSaint-PierreFranceUnknown status
AP-HP Hôpital FochSuresnesFranceUnknown status
CHU ToulouseToulouseFranceUnknown status
CHU ToursToursFranceUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.