Cystic Fibrosis LungMucoFong2NCT03753828
Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.
An observational study of Cystic Fibrosis Lung, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis Lung
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2017to 13 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cystic Fibrosis Lung
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients de novo colonized by fungi | Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the micromycetes find in lung in patients with cystic fibrosis
Relation between the micromycetes and the pathologic lung in patients with cystic fibrosis
Measured: Day 1
Secondary outcomes (2)
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)
Measured: 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.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start13 Jul 2017
- Primary completion13 Oct 2018
- Study completion13 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis LungStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence DELHAES, MD/PhD, Principal investigator, Hospital University, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753828
- Sponsor's protocol ID
- CHUBX 2017/34
- Acronym
- MucoFong2
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.
- ClinicalTrials.gov ID
- NCT03753828
- Acronym / sponsor ID
- MucoFong2 / CHUBX 2017/34
- Conditions
- Cystic Fibrosis Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 13 Oct 2018 (actual)
- Study completion
- 13 Oct 2018 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients de novo colonized by fungi | – | –Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Number of patient with a. fumigatus, c. albicans or other micromycete
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.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence DELHAES, MD/PhD principal investigator
Hospital University, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis Lung, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the micromycetes find in lung in patients with cystic fibrosis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.