Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT06044051
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'description of microbiomes from bronchoalveolar fluids', 'timeFrame': 'Inclusion', 'description': 'analysis of bronchoalveolar fluids - NGS sequencing'}, {'measure': 'description of microbiomes from nasopharyngeal samples', 'timeFrame': 'Inclusion', 'description': 'analysis of nasopharyngeal samples- NGS sequencing'}, {'measure': 'description of microbiomes from sputum samples', 'timeFrame': 'Inclusion', 'description': 'analysis of sputum samples- NGS sequencing'}, {'measure': 'description of microbiomes from bronchoalveolar fluids', 'timeFrame': 'at 3 months', 'description': 'analysis of bronchoalveolar fluids- NGS sequencing'}, {'measure': 'description of microbiomes from nasopharyngeal samples', 'timeFrame': 'at 3 months', 'description': 'analysis of nasopharyngeal samples- NGS sequencing'}, {'measure': 'description of microbiomes from sputum samples', 'timeFrame': 'at 3 months', 'description': 'analysis of sputum samples- NGS sequencing'}, {'measure': 'description of microbiomes from bronchoalveolar fluids', 'timeFrame': 'at 6 months', 'description': 'analysis of bronchoalveolar fluids- NGS sequencing'}, {'measure': 'description of microbiomes from nasopharyngeal samples', 'timeFrame': 'at 6 months', 'description': 'analysis of nasopharyngeal samples- NGS sequencing'}, {'measure': 'description of microbiomes from sputum samples', 'timeFrame': 'at 6 months', 'description': 'analysis of sputum samples- NGS sequencing'}, {'measure': 'description of microbiomes from bronchoalveolar fluids', 'timeFrame': 'at 9 months', 'description': 'analysis of bronchoalveolar fluids - NGS sequencing'}, {'measure': 'description of microbiomes from nasopharyngeal samples', 'timeFrame': 'at 9 months', 'description': 'analysis of nasopharyngeal samples- NGS sequencing'}, {'measure': 'description of microbiomes from sputum samples', 'timeFrame': 'at 9 months', 'description': 'analysis of sputum samples- NGS sequencing'}, {'measure': 'description of microbiomes from bronchoalveolar fluids', 'timeFrame': 'at 12 months', 'description': 'analysis of bronchoalveolar fluids- NGS sequencing'}, {'measure': 'description of microbiomes from nasopharyngeal samples', 'timeFrame': 'at 12 months', 'description': 'analysis of nasopharyngeal samples- NGS sequencing'}, {'measure': 'Description of microbiomes from sputum samples', 'timeFrame': 'at 12 months', 'description': 'analysis of sputum samples- NGS sequencing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiosme', 'Asthma in infant'], 'conditions': ['Asthma in Children', 'Asthma']}, 'referencesModule': {'references': [{'pmid': '40670979', 'type': 'DERIVED', 'citation': 'Petat H, Hassel C, Michel A, Charbonnier C, Plantier JC, Marguet C. Microbiosthma: a prospective study following respiratory microbiota in young children with severe preschool wheezing to better understand their respiratory future. BMC Pulm Med. 2025 Jul 16;25(1):342. doi: 10.1186/s12890-025-03812-9.'}]}, 'descriptionModule': {'briefSummary': 'Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.\n\nExploring and understanding these data is to improve patient care and discover new therapeutic targets.\n\nThe aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants less than 24 months old\n* Follow-up by a pneumo-pediatrician for severe asthma in infants\n* Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)\n* Parent informed of the research and having signed consent\n\nExclusion Criteria:\n\n* Prematurity \\<32 WA\n* Congenital heart disease with significant left to right shunt\n* Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)\n* Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)\n* Refusal of bronchial fibroscopy'}, 'identificationModule': {'nctId': 'NCT06044051', 'acronym': 'Microbiosthme', 'briefTitle': 'Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': "Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons", 'orgStudyIdInfo': {'id': '2023/0091/OB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All patients', 'description': 'All patients included will be followed for 1 year, every 3 months', 'interventionNames': ['Other: Blood sample', 'Other: Expectoration', 'Other: Nasopharyngeal swab']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'An additionnal volume of blood will be collected at inclusion and at each follow-up visit', 'armGroupLabels': ['All patients']}, {'name': 'Expectoration', 'type': 'OTHER', 'description': 'Expectoration will be collected at inclusion and at each follow-up visit', 'armGroupLabels': ['All patients']}, {'name': 'Nasopharyngeal swab', 'type': 'OTHER', 'description': 'A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hortense PETAT', 'role': 'CONTACT'}], 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'David Mallet', 'role': 'CONTACT', 'email': 'secretariat.DRC@chu-rouen.fr', 'phone': '02 32 88 82 65', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'PETAT Hortense', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}