Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-28 @ 8:01 AM
Study NCT ID:
NCT04550767
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
: Bacterial Infections in Injecting Drug Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D015819', 'term': 'Substance Abuse, Intravenous'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Types of bacterial infections', 'timeFrame': '1 day', 'description': 'Types of bacterial infections : local or systemic:'}, {'measure': 'Psychoactive substances involved in each type of bacterial infections', 'timeFrame': '1 day', 'description': 'Psychoactive substances involved in each type of bacterial infections'}, {'measure': 'Types of injections in each type of infections', 'timeFrame': '1 day', 'description': 'Types of injections in each type of infections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychoactive substance', 'Intravenous substance abuse', 'Injection drug user', 'Risk reduction', 'Psychoactive substances'], 'conditions': ['Bacterial Infection']}, 'descriptionModule': {'briefSummary': 'Bacterial infections in people who inject psychoactive substances', 'detailedDescription': 'In context of an increase of bacterial infections in people who inject psychoactive substances (PS) all around the world and a lack of available scientific data, the investigators decided to set up a descriptive study on bacterial infection types and determinants in Injection Drug Users (IDUs).\n\nThrough a multidisciplinary approach between hospital departments (e.g. infectious diseases, emergency and addictology), the local addiction management and liaison team (ELSA) and the regional addictovigilance center, data were collected on appearance and course of bacterial infections in IDUs hospitalized at Montpellier University Hospital, France.\n\nThis study aims to provide medical data in order to better understand those infections and their determinants and provide information for potential future more specific observational studies.\n\nThe regional addictovigilance center is a member of the French Addictovigilance Network, which was established to monitor the potential for abuse and dependence of PS, and to provide information on the risk of addiction and advice for public health decision making, under the supervision of the French National Agency for Medicines and Health Products Safety. This surveillance system is principally based on spontaneous reporting by healthcare professionals and patients that is regulated by law. Collected data were extracted from those spontaneous reports (composed by data from the medical file\\*, DxCare or notification by medical team). First data were collected in 2012.\n\nIn addition, the investigators offered patients to fill in an anonymous questionnaire\\*\\* on hygiene habits which was not mandatory and had no influence on treatment, and was offered during the ELSA team intervention (questions from the questionnaire are classical risk reduction question on injection and hygiene practices).\n\nMain results are the description of the infections and injection practices. There is no control group per se as all included patients are IDUs and have a bacterial infection. But the investigators infection (such as abscess or skin and soft tissue) and those with a systemic infection. The two groups were established after the recruitment was completed. This comparative analysis is only performed in order to better understand the development of infections. Descriptive and comparative analyses was performed by the Department of Medical Information.\n\n\\*Data collected :\n\n* Age\n* Sex\n* Past history of bacterial infection linked to injection of a psychoactive substance\n* HIV and HCV status\n* Injected psychoactive substance\n* Injection practices (frequency, route, location)\n* Diagnosis\n* Bacterial analysis\n* Treatments and course\n\n * Hygiene questionnaire (attached file)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes all injection drug users, hospitalized at Montpellier University Hospital for bacterial infection related to the injection of one or several psychoactive substance(s).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Bacterial infection occurring in injection drug users and linked to injection\n* Hospitalized at Montpellier University Hospital\n\nExclusion criteria:\n\n* No injection\n* No use of a psychoactive substance\n* Viral or fungal infection'}, 'identificationModule': {'nctId': 'NCT04550767', 'briefTitle': ': Bacterial Infections in Injecting Drug Users', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Bacterial Infections in People Who Inject Psychoactive Substances', 'orgStudyIdInfo': {'id': 'RECHMPL20_0523'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'local infections', 'description': 'local infections'}, {'label': 'systemic infections', 'description': 'systemic infections'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34290', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Hélène Peyrière, PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}