Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 1:03 AM
Study NCT ID:
NCT04065750
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of bacteraemia', 'timeFrame': 'through study completion, an average of 3 months'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'at 30 day and 90 day', 'description': 'Events of death will be recorded, the mortality rate will be calculated for 30 day and 90 day.'}, {'measure': 'Rehospitalization', 'timeFrame': '12 months', 'description': 'The rate of 12 months unplanned rehospitalization for infection by the same biological pathogenes was recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bacteremia', 'resistant bacteria', 'antibiotic'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to identify the risk factors of community-acquired bacteremia to resistant bacteria.\n\nAs the secondary objectives, the study aims\n\n* to describe the episodes of epidemiology of bacteremia (community-acquired and nosocomial) with inpatient patients in APHP.\n* to research a potential correlation between the incidence of community-acquired bacteremia of studied germs and the evolution of antibiotics consumption in general population in Île de France region.\n* to distinguish three categories of community-acquired bacteremia: real community-acquired infections, infections beginning in community (patients discharged a community care center within 3 months), the nosocomial infections (patients discharged a health center within 7 jours). Describe the epidemiology of resistance and the differential impact of individual exposure to antibiotics in these three categories.\n* to identify, according to pathogens, a temporal threshold from which a prior stay in a health center or HAD would impact on the occurrence of a community-acquired bacteremia with a resistant bacterium.\n* to describe prospectively for follow-up of 1 year for hospitalized patients for a community-acquired or nosocomial bacteremia: mortality at one month and 3 months, re-hospitalization for an infectious episode and isolated bacteria during this later episode.', 'detailedDescription': 'The investigators will study in particularly individual exposure to antibiotics: exposure in 3 months ou in 12 months, cumulative exposure, hospital- and community-acquired exposure, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bacteremia cohort: all inpatient patients in a hospital of APHP between January 2010 and december 2018 with at least one haemoculture positive.\n\nControl cohort: patients cared in a hospital of APHP between 2010 and 2018 without infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor bacteraemia cohort:\n\nAll inpatient patients in a hospital of APHP between January 2010 and december 2018 with at least one haemoculture positive.\n\n* presence of at least a bacteremia as primary diagnosis, related diagnosis and associated diagnosis: A40 (streptococcus), A41 (staphylococcus, BGN, anaerobes, others), A32.7 (Listeria), A39.4 (meningocoele), A42.7 (Actinomyces), A02.1 (Salmonella), A54.8 (gonocoque), A48.0 (Clostridium).\n* and/or in biological data presence of at least a haemoculture positive to Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Acinetobacter Baumannii, Enterococcus faecium, Enterococcus faecalis, Enterobacter cloacae, Pseudomonas aeruginosa, Streptococcus sp., Salmonella sp., Clostridium difficile.\n\nFor control cohort:\n\nPatients cared in a hospital of APHP between 2010 and 2018 without infection. - Patients without infection of CIM-10 bacteraemia as primary diagnosis, related diagnosis and associated diagnosis, without haemoculture positive in microbiology.\n\nExclusion Criteria:\n\n\\- Patients aged \\< 18 years'}, 'identificationModule': {'nctId': 'NCT04065750', 'acronym': 'BactHub', 'briefTitle': 'Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Exposure to Antibiotics and Incidence of Bacteraemia Caused by Resistant Bacteria', 'orgStudyIdInfo': {'id': 'APHP190295'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Laurence Watier, PhD', 'role': 'CONTACT', 'email': 'Laurence.watier@inserm.fr', 'phone': '+33 (0) 1 45 68 83 01'}, {'name': 'Salam Abbara, MD, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Laurence Watier, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSERM / Institut Pasteur'}, {'name': 'Didier Guillemont, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP, Université de Versailles Saint-Quentin-en-Yvelines'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Versailles Saint-Quentin-en-Yvelines University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}