NCT06371261

Brief Summary

The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation, making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned. However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification. In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2024Mar 2027

Study Start

First participant enrolled

March 12, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 2, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

Achromobacter speciesMALDI-TOF mass spectrometryRéunion Island

Outcome Measures

Primary Outcomes (1)

  • Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients.

    The occurrence of pulmonary exacerbations as a function of the species of the genus Achromobacter spp. Colonising/infecting patients.

    2 years

Secondary Outcomes (5)

  • Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status.

    2 years

  • Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses.

    2 years

  • Presence of virulence factors in these strains using genomic analyses

    2 years

  • Search for genes responsible for antibiotic resistance by genomic analysis of these strains

    2 years

  • To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion

    2 years

Interventions

A cytobacteriological examination of the sputum will be carried out and sent to the microbiology laboratory at the University Hospital of La Réunion. The micro-organisms will be quantified. The micro-organisms, and more specifically bacteria of the Achromobacter genus, will be identified by MALDI-TOF mass spectrometry using the published database (Garrigos et al.2021).

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of cystic fibrosis patients from Reunion island with Achromobacter spp colonisation

You may qualify if:

  • Minor or major cystic fibrosis patients
  • Patients living in La Réunion island.
  • Patients for whom a non-opposition was obtained orally (if applicable from both one of the child's legal guardians and the child him/herself)

You may not qualify if:

  • Patients without cystic fibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU la Réunion North

Saint-Denis, Reunion

Location

CHU la Réunion South

Saint-Pierre, Reunion

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Biological Oxygen Demand Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Environmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Thomas GARRIGOS, Pharm D, PhD

    CHU La Réunion

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 17, 2024

Study Start

March 12, 2024

Primary Completion (Estimated)

March 19, 2027

Study Completion (Estimated)

March 19, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations