Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database. (MucoFong2)

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis Lung

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.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• France
  • Bourdeaux, France, 33000
    • University Hospital, Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

300 patients followed for 2 years including a subpopulation of 40 patients with pro-and eukaryotic respiratory microbiota documented by high-throughput sequencing.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients de novo colonized by fungi; Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Laurence DELHAES, MD/PhD, Hospital University, Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2017
• Primary Completion (ACTUAL): October 13, 2018
• Study Completion (ACTUAL): October 13, 2018

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: CHUBX 2017/34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No