Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database. (MucoFong2)
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|ClinicalTrials.gov Identifier: NCT03753828|
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : May 6, 2019
|Condition or disease|
|Cystic Fibrosis Lung|
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|
|Actual Enrollment :||57 participants|
|Official Title:||Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.|
|Actual Study Start Date :||July 13, 2017|
|Actual Primary Completion Date :||October 13, 2018|
|Actual Study Completion Date :||October 13, 2018|
patients de novo colonized by fungi
Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up
- Describe the micromycetes find in lung in patients with cystic fibrosis [ Time Frame: Day 1 ]Relation between the micromycetes and the pathologic lung in patients with cystic fibrosis
- Number of patient with a. fumigatus, c. albicans or other micromycete [ Time Frame: Day 1 ]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)
- 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. [ Time Frame: 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753828
|University Hospital, Bordeaux|
|Bourdeaux, France, 33000|
|Principal Investigator:||Laurence DELHAES, MD/PhD||Hospital University, Bordeaux|