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Active, not recruitingNCT06371261ACHROMO-MUCOUpdated May 4, 2026

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

An observational study in Cystic Fibrosis, sponsored by Centre Hospitalier Universitaire de la Réunion. Active, not recruiting at 2 sites in Reunion. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cystic Fibrosis

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Keywords

  • Achromobacter species
  • MALDI-TOF mass spectrometry
  • Réunion Island
03

In context

Cystic Fibrosis

1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.

This study's enrollment of 17 is below the median of 85 across 503 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients without cystic fibrosis.
  • Patients with cystic fibrosis but no Achromobacter-positive ECBC during the study inclusion period
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Interventions

  • OtherBiological 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).

06

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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

    Time frame: 2 years

  3. Presence of virulence factors in these strains using genomic analyses

    Study of the virulome: whole genome sequencing in search of virulence genes

    Time frame: 2 years

  4. 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

    Time frame: 2 years

  5. 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

    Time frame: 2 years

07

Study locations

2 sites
  • CHU la Réunion North
    Saint-Denis, Reunion
  • CHU la Réunion South
    Saint-Pierre, Reunion
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.

Of 228 non-industry observational studies under Cystic Fibrosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 89. This study's planned 36 months is close to that.

Counting every sponsor, half of 243 studies reached it within 41 months; a quarter within 19 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2024
First posted
Apr 17, 2024
StartActual
Mar 12, 2024
Primary completionEst.
Mar 19, 2027
CompletionEst.
Mar 19, 2027
Last update
May 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06371261
Responsible party
Sponsor
First posted
Apr 17, 2024
Start date
Mar 12, 2024
Primary completion
Mar 19, 2027 (estimated)
Completion
Mar 19, 2027 (estimated)
Last update
May 4, 2026

Study contacts

Thomas GARRIGOS, Pharm D, PhD
study director · CHU La Réunion

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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