Cystic FibrosisACHROMO-MUCONCT06371261
Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Biological analyses
- How many people
- 17 participants
- Where
- 2 sitesReunion
- Study dates
- 12 Mar 2024to 19 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Cohort of cystic fibrosis patients from Reunion island with Achromobacter spp colonisation
Who may be able to join
- 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)
Who cannot join
- Patients without cystic fibrosis.
- Patients with cystic fibrosis but no Achromobacter-positive ECBC during the study inclusion period
Trial locations and contacts
2 sites in 1 country.
Reunion2 sites
CHU la Réunion North
Saint-Denis
CHU la Réunion South
Saint-Pierre
About this study
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.
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.
Read the detailed 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Biological analyses
- Keywords
- Achromobacter species, MALDI-TOF mass spectrometry, Réunion Island
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological analysesOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
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.
Measured: 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.
Clonality between strains: whole genome sequencing with genotyping between strains
Measured: 2 years
Presence of virulence factors in these strains using genomic analyses
Study of the virulome: whole genome sequencing in search of virulence genes
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start12 Mar 2024
- Primary completion19 Mar 2027 (estimated)
- Study completion19 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas GARRIGOS, Pharm D, PhD, Study director, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371261
- Sponsor's protocol ID
- 2023/CHU/07
- Acronym
- ACHROMO-MUCO
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06371261
- Acronym / sponsor ID
- ACHROMO-MUCO / 2023/CHU/07
- Conditions
- Cystic Fibrosis
- Keywords
- Achromobacter species, MALDI-TOF mass spectrometry, Réunion Island
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 19 Mar 2027 (estimated)
- First posted
- 17 Apr 2024 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort of cystic fibrosis patients from Reunion island with Achromobacter spp colonisation
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients without cystic fibrosis.
- Patients with cystic fibrosis but no Achromobacter-positive ECBC during the study inclusion period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological analysesA 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). | Other | – |
Primary outcome
Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients.
Time frame: 2 years
The occurrence of pulmonary exacerbations as a function of the species of the genus Achromobacter spp. Colonising/infecting patients.
5 secondary outcomes
Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status.
Time frame: 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.
Time frame: 2 years
Presence of virulence factors in these strains using genomic analyses
Time frame: 2 years
Search for genes responsible for antibiotic resistance by genomic analysis of these strains
Time frame: 2 years
To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Thomas GARRIGOS, Pharm D, PhD study director
CHU La Réunion
2 sites 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, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Reunion. 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?
This study is still under way. Results are not available in the source record yet.
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?
Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients. (time frame: 2 years). 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 4 May 2026.