Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.

NCT ID: NCT03753828

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2018-10-13

Brief Summary

The main objective of the project "MucoFong" (19021906 national french program n which Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the respiratory tract of CF patients responsible for either colonization or authentic infectious diseases. The Mucofong data allowed the team to provide for the 1st time national French guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has a comprehensive database that it still has to analyze beyond these initial results. The main goal today is to clarify the role of fungi in the lung function degradation of these patients by studying the overall risk and estimated impact of fungal colonization in our cohort.

Detailed Description

The material includes data from the followup of the 300 patients (3 visits per patient for which the team collected and verified the biological radiological and clinical data).

Relations between Aspergillus fumigatus or Candida albicans and lung function or clinical outcome of patients will be longitudinally analyzed taking as output variable FEV1, according to bibliography data available.

To assess the attributed fungal risk, the team will focus on the 57 patients de novo colonized by fungi at the second visit. Three physician experts will determine the impact of such fungal colonization on the patient clinical and respiratory parameters.

The expert conclusion concordance and statistical significance will be evaluated using the kappa score.

This project will be realized in collaboration with the groups of Prof. R. Thiebaut (Methodology and Epidemiology Service Bordeaux University Hospital, INSERM U1219 / INRIA SISTM) and Prof. M. Fayon (Department of Pediatrics, Pediatric reference centre) University Hospital of Bordeaux.

Conditions

Cystic Fibrosis Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients de novo colonized by fungi

Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

All patients included in the database meet the following criteria:

• Patient whose diagnosis of cystic fibrosis has been validated on the criteria in force,
• Patient usually followed in one of the 7 centers involved in the PHRC,
• Patient aged at least 6 years without an upper age limit,
• Patient benefiting from a mycological assessment carried out in the context of the usual microbiological monitoring (good clinical practice),
• Cystic fibrosis Patient benefiting from a mycological assessment carried out in front of a clinical episode of aggravation requiring biological exploration,
• Patient who has signed informed consent at the time of inclusion,-patient affiliated with a social security scheme.

Exclusion Criteria

Patients meeting the following criteria were not included in the database:

• Pulmonary transplant Patient,
• Patient or their parents (if the patient is a minor) refusing any participation in the study,
• Major incapable subject, under guardianship or under the protection of Justice,
• Refusal or inability to give informed consent.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence DELHAES, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital University, Bordeaux

Locations

University Hospital, Bordeaux

Bourdeaux, , France

Countries

France

Other Identifiers

CHUBX 2017/34

Identifier Type: -

Identifier Source: org_study_id