Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 1232 for:    cystic fibrosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753828
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease
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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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
Cystic Fibrosis sputum mycological analysis


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
France
University Hospital, Bordeaux
Bourdeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Layout table for investigator information
Principal Investigator: Laurence DELHAES, MD/PhD Hospital University, Bordeaux

Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03753828     History of Changes
Other Study ID Numbers: CHUBX 2017/34
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases