NCT04735679

Brief Summary

The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients. The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy. All patients followed at the Montpellier CF center will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 5, 2021

Status Verified

January 1, 2021

Enrollment Period

2.9 years

First QC Date

January 29, 2021

Last Update Submit

February 2, 2021

Conditions

Keywords

MICROBIOLOGYMULTI-OMICSPUTUMPULMONARY MICROBIOTACYSTIC FIBROSISCOHORTANTIBIOTHERAPY

Outcome Measures

Primary Outcomes (3)

  • to determine a characterisation of the microorganisms of the lung microbiota

    to characterise the microorganisms of the lung microbiota and their interspecific interactions by taxonomic and functional analyses.

    1 day

  • to determine a ink between the Composition of the microbiota

    To demonstrate the relationship between the composition of the microbiota and the evolution of the disease Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis

    1 day

  • to determine a Effectiveness of antibiotic therapy

    To identify abiotic conditions that may contribute to the gap between the efficacy of antibiotics in vitro and in vivo. Show that the microbiota plays a role in the effectiveness of antibiotic treatment.

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cystic fibrosis patients

You may qualify if:

  • \- Cystic fibrosis patient

You may not qualify if:

  • \- Refusal to participate in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Raphael CHIRON, PU-PH

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael CHIRON, PU-PH

CONTACT

Alexandre COUDRAT

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

February 5, 2021

Record last verified: 2021-01

Locations