Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371261
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-02
Brief Title:
Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACHROMO-MUCO
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 andor is more responsible for chronic colonisation
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 andor 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 colonizinginfecting 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
Investigator will therefore assess the frequency of pulmonary exacerbations as a function of the Achromobacter species colonizinginfecting 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None