Cystic Fibrosis Lung Clinical Trial
Official title:
Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.
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.
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.
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