ClinicalTrials.gg
Sign In
CompletedNCT03753828MucoFong2Updated May 6, 2019

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

An observational study in Cystic Fibrosis Lung, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
57
Ages
6 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cystic Fibrosis Lung

Browse trials for

03

In context

Cystic Fibrosis

1,605 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.

This study's enrollment of 57 is below the median of 85 across 489 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Browse University Hospital, Bordeaux studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
57 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • patients de novo colonized by fungi

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

06

What researchers measure

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

    Time frame: Day 1

Secondary outcomes

  1. 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)

    Time frame: Day 1

  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.

    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

07

Study locations

1 site
  • University Hospital, Bordeaux
    Bourdeaux, 33000, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Oct 2018, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2018
First posted
Nov 27, 2018
StartActual
Jul 13, 2017
Primary completionActual
Oct 13, 2018
CompletionActual
Oct 13, 2018
Last update
May 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03753828
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Nov 27, 2018
Start date
Jul 13, 2017
Primary completion
Oct 13, 2018
Completion
Oct 13, 2018
Last update
May 6, 2019

Study contacts

Laurence DELHAES, MD/PhD
principal investigator · Hospital University, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cystic Fibrosis →

Other studies from this sponsor

University Hospital, Bordeaux →

Start the discussion