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

NCT03753828 | Completed

• 1 other identifier: CHUBX 2017/34
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patient with a. fumigatus, c. albicans or other micromycete

  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.

  Day 1

Study Arms (1)

patients de novo colonized by fungi

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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital, Bordeaux

Bourdeaux, 33000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cystic Fibrosis sputum mycological analysis

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Laurence DELHAES, MD/PhD

  Hospital University, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: November 27, 2018
• Study Start: July 13, 2017
• Primary Completion: October 13, 2018
• Study Completion: October 13, 2018
• Last Updated: May 6, 2019

Record last verified: 2018-08

Locations

FR (1)