Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— ACHROMO-MUCO  

Official title:

Pathogenicity of Species of the Achromobacter Genus in Patients With Cystic Fibrosis: a Prospective Multicentre Exploratory Study of a Cohort in Réunion Island.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371261
• Other study ID #: 2023/CHU/07
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Thomas GARRIGOS, Pharm D, PhD
• Phone: +262 (0)2 62 90 62 67
• Email: thomas.garrigos[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The research hypotheses are: What is the pathogenicity of Achromobacter species in cystic fibrosis patients? Is the pathogenicity of one species of the genus Achromobacter greater than that of other species in cystic fibrosis patients, depending on the colonization status of this bacterial species? Colonization with a species of the genus Achromobacter is associated with an increased frequency of pulmonary exacerbations in cystic fibrosis patients. Investigator will therefore assess the frequency of pulmonary exacerbations as a function of the Achromobacter species colonizing/infecting cystic fibrosis patients. As this is an exploratory study carried out mainly on bacterial strains from patients, it presents no risk to patients. the results of the study will enable clinicians to improve their knowledge of the different species of bacteria in the Achromobacter genus, in terms of pathogenicity, ability to colonize the respiratory tract, resistance and virulence. As far as patients are concerned, the knowledge gained from this study will help improve the overall management of their disease. It will also provide food for thought on the establishment of guidelines and recommendations for dealing with Achromobacter spp. colonization and therapeutic strategy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Minor or major cystic fibrosis patients
• Patients with at least one sputum cytobacteriological test positive for Achromobacter spp. during the inclusion period.
• 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)

Exclusion Criteria:

• Patients without cystic fibrosis.
• Patients with cystic fibrosis but no Achromobacter-positive ECBC during the study inclusion period

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Biological analyses
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).

Locations

Country	Name	City	State
Réunion	CHU la Réunion North	Saint-Denis
Réunion	CHU la Réunion South	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status.	The occurrence of pulmonary exacerbations according to the colonisation statuses defined according to the French National Diagnostic and Care Protocol (PNDS)-Mucoviscidose of the French National Authority for Health (HAS) July 2017.	2 years
Secondary	Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses.	Clonality between strains: whole genome sequencing with genotyping between strains	2 years
Secondary	Presence of virulence factors in these strains using genomic analyses	Study of the virulome: whole genome sequencing in search of virulence genes	2 years
Secondary	Search for genes responsible for antibiotic resistance by genomic analysis of these strains	Study of the resistome: whole genome sequencing in search of resistance genes, antibiotic sensitivity tests	2 years
Secondary	To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion	Prevalence of chronic colonisation with Achromobacter spp. and prevalence of colonisation according to Achromobacter species	2 years