Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT02751658
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tap to "Tap", Pathobiome Associates Health Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Pseudomonas aeruginosa', 'timeFrame': 'Entrance hospitalization (Day 1)', 'description': 'The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients admitted to the hospital entrance.\n\nMark of Pseudomonas aeruginosa will be done with and without trypticase soy broth enrichment and isolation on selective agar cetrimide Pseudomonas aeruginosa . The enrichment will detect a port at very low inoculum knowing that the purpose of the analysis is to detect passing of Pseudomonas aeruginosa from the environment to the patient regardless of the associated infectivity. The identification of certainty will be carried out by MALDI-TOF. If several morphotypes are visualized on agar Cetrimide they will all be identified and kept under custody broth at -20 ° C.'}], 'secondaryOutcomes': [{'measure': 'Presence of infection with Pseudomonas aeruginosa', 'timeFrame': 'Exit hospitalization (Day 10)', 'description': 'The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients exit hospitalization.\n\nMark of Pseudomonas aeruginosa will be done with and without trypticase soy broth enrichment and isolation on selective agar cetrimide Pseudomonas aeruginosa . The enrichment will detect a port at very low inoculum knowing that the purpose of the analysis is to detect passing of Pseudomonas aeruginosa from the environment to the patient regardless of the associated infectivity. The identification of certainty will be carried out by MALDI-TOF. If several morphotypes are visualized on agar Cetrimide they will all be identified and kept under custody broth at -20 ° C.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Otorhinolaryngologic Diseases']}, 'referencesModule': {'references': [{'pmid': '37902330', 'type': 'DERIVED', 'citation': 'Benigno V, Carraro N, Sarton-Loheac G, Romano-Bertrand S, Blanc DS, van der Meer JR. Diversity and evolution of an abundant ICEclc family of integrative and conjugative elements in Pseudomonas aeruginosa. mSphere. 2023 Dec 20;8(6):e0051723. doi: 10.1128/msphere.00517-23. Epub 2023 Oct 30.'}, {'pmid': '35205346', 'type': 'DERIVED', 'citation': 'Virieux-Petit M, Hammer-Dedet F, Aujoulat F, Jumas-Bilak E, Romano-Bertrand S. From Copper Tolerance to Resistance in Pseudomonas aeruginosa towards Patho-Adaptation and Hospital Success. Genes (Basel). 2022 Feb 4;13(2):301. doi: 10.3390/genes13020301.'}]}, 'descriptionModule': {'briefSummary': 'The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care', 'detailedDescription': 'Goals :\n\nKey: To study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium.\n\nsecondary:\n\n1. Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources.\n2. To evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with P. aeruginosa.\n\nExperimental Study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the Otorhinolaryngology department\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* Patient Opposition to enter the research protocol'}, 'identificationModule': {'nctId': 'NCT02751658', 'acronym': 'TapPAS', 'briefTitle': 'Tap to "Tap", Pathobiome Associates Health Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections', 'orgStudyIdInfo': {'id': '9648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients in the Otorhinolaryngology', 'description': 'patients in the Otorhinolaryngology department realization of a levy into the mouth swab on the day of admission to hospital and the day of release', 'interventionNames': ['Other: mouth swab']}], 'interventions': [{'name': 'mouth swab', 'type': 'OTHER', 'description': 'Levy to make inside of the mouth with a swab on the day of admission to hospital and the day of release at the patients in the Otorhinolaryngology', 'armGroupLabels': ['patients in the Otorhinolaryngology']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sara ROMANO-BERTRAND, MCU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}