Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT06371261
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057919', 'term': 'Biological Oxygen Demand Analysis'}], 'ancestors': [{'id': 'D004784', 'term': 'Environmental Monitoring'}, {'id': 'D004781', 'term': 'Environmental Exposure'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients.', 'timeFrame': '2 years', 'description': 'The occurrence of pulmonary exacerbations as a function of the species of the genus Achromobacter spp. Colonising/infecting patients.'}], 'secondaryOutcomes': [{'measure': 'Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status.', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses.', 'timeFrame': '2 years', 'description': 'Clonality between strains: whole genome sequencing with genotyping between strains'}, {'measure': 'Presence of virulence factors in these strains using genomic analyses', 'timeFrame': '2 years', 'description': 'Study of the virulome: whole genome sequencing in search of virulence genes'}, {'measure': 'Search for genes responsible for antibiotic resistance by genomic analysis of these strains', 'timeFrame': '2 years', 'description': 'Study of the resistome: whole genome sequencing in search of resistance genes, antibiotic sensitivity tests'}, {'measure': 'To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion', 'timeFrame': '2 years', 'description': 'Prevalence of chronic colonisation with Achromobacter spp. and prevalence of colonisation according to Achromobacter species'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Achromobacter species', 'MALDI-TOF mass spectrometry', 'Réunion Island'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.\n\nHowever, 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.\n\nIn 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.', 'detailedDescription': '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.\n\nInvestigator will therefore assess the frequency of pulmonary exacerbations as a function of the Achromobacter species colonizing/infecting cystic fibrosis patients.\n\nAs this is an exploratory study carried out mainly on bacterial strains from patients, it presents no risk to patients.\n\nthe 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.\n\nAs 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of cystic fibrosis patients from Reunion island with Achromobacter spp colonisation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minor or major cystic fibrosis patients\n* Patients with at least one sputum cytobacteriological test positive for Achromobacter spp. during the inclusion period.\n* Patients living in La Réunion island.\n* 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)\n\nExclusion Criteria:\n\n* Patients without cystic fibrosis.\n* Patients with cystic fibrosis but no Achromobacter-positive ECBC during the study inclusion period"}, 'identificationModule': {'nctId': 'NCT06371261', 'acronym': 'ACHROMO-MUCO', 'briefTitle': 'Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Pathogenicity of Species of the Achromobacter Genus in Patients With Cystic Fibrosis: a Prospective Multicentre Exploratory Study of a Cohort in Réunion Island.', 'orgStudyIdInfo': {'id': '2023/CHU/07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biological analyses', 'type': 'OTHER', 'description': 'A cytobacteriological examination of the sputum will be carried out and sent to the microbiology laboratory at the University Hospital of La Réunion.\n\nThe micro-organisms will be quantified.\n\nThe 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).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Denis', 'status': 'RECRUITING', 'country': 'Reunion', 'contacts': [{'name': 'VERHILLE Juliette, MD', 'role': 'CONTACT', 'email': 'Juliette.verhille@chu-reunion.fr'}, {'name': 'Juliette VERHILLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU la Réunion North', 'geoPoint': {'lat': -20.88231, 'lon': 55.4504}}, {'city': 'Saint-Pierre', 'status': 'RECRUITING', 'country': 'Reunion', 'contacts': [{'name': 'PERISSON Caroline, MD', 'role': 'CONTACT', 'email': 'Caroline.perisson@chu-reunion.fr'}, {'name': 'Caroline PERISSON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU la Réunion South', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'centralContacts': [{'name': 'Thomas GARRIGOS, Pharm D, PhD', 'role': 'CONTACT', 'email': 'thomas.garrigos@chu-reunion.fr', 'phone': '+262 (0)2 62 90 62 67'}, {'name': 'Bénédicte Artarit', 'role': 'CONTACT', 'email': 'benedicte.artarit@chu-reunion.fr'}], 'overallOfficials': [{'name': 'Thomas GARRIGOS, Pharm D, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU La Réunion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}