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

Cystic Fibrosis Lung Clinical Trial

— MucoFong2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753828
• Other study ID #: CHUBX 2017/34
• Status: Completed
• Start date: July 13, 2017
• Est. completion date: October 13, 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 13, 2018
• Est. primary completion date: October 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis Lung
• Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
France	University Hospital, Bordeaux	Bourdeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the micromycetes find in lung in patients with cystic fibrosis	Relation between the micromycetes and the pathologic lung in patients with cystic fibrosis	Day 1
Secondary	Number of patient with a. fumigatus, c. albicans or other micromycete	Establish the proportion of patients of a colonization in a. fumigatus, in c. albicans or other micromycete, carriers from awareness of a. fumigatus (unlike an ABPA)	Day 1
Secondary	Detect, from data of high-throughput sequencing, combinations of bacteria or fungi are present and clear profile of affinity between genres, in patients with cystic fibrosis.	Detect, from data of high-throughput sequencing, combinations of bacteria or fungi are present and clear profile of affinity between genres, in patients with cystic fibrosis	Day 1