Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-02 @ 4:14 PM
Study NCT ID:
NCT06425367
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'cluster cross-over randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 960}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Antiobiotherapy', 'timeFrame': '12 hours', 'description': 'percentage of patients with Enterobacterales bacteremia for whom antibiotic therapy was effective against the incriminating bacterium within 12 hours of a positive blood culture, according to the results of the antibiogram.'}], 'secondaryOutcomes': [{'measure': 'Time Frame', 'timeFrame': '3days', 'description': 'Time between blood sampling and antibiogram results'}, {'measure': 'type of Antibiotherapy spectra modification', 'timeFrame': '2 days', 'description': 'After obtaining the antibiogram result, was the antibiotherapy modified (Yes or No) and if yes, was it for narrowing the antibiotic spectra (yes or no)'}, {'measure': 'Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results', 'timeFrame': '2 days', 'description': 'in hours'}, {'measure': 'time between the start of intravenous antibiotic therapy and oral antibiotics.', 'timeFrame': '1month', 'description': 'in days'}, {'measure': 'length of hospital stay', 'timeFrame': '1 month', 'description': 'In days,'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiogram', 'bacteremia'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'Bacteremia is defined as the presence of bacteria in the blood. They can potentially lead to life-threatening septic shock.\n\nEffective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken.\n\nTo diagnose bacteremia, blood culture bottles must first be incubated, which allows bacterial growth and early detection. Then, as soon as the sample is positive, an antibiogram of the incriminated bacterium is carried out by inoculation on MH (Mueller Hinton) medium. This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive, i.e. around 48 hours after blood cultures are taken.\n\nAmerican recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram. Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy. They can also be used to reduce the spectrum of broad-spectrum antibiotics. This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria (MRB) or highly resistant bacteria (HRB). Finally, it is also possible to carry out an early oral relay, thus avoiding intravenous infusions and their complications, and potentially reducing hospitalization times.\n\nThe investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. The investigators were able to obtain antibiogram results 7 hours after blood culture positivity, with excellent correlation compared with the standard method after 24 hours incubation on MH (Mueller-Hinton). The antibiotics tested were the same as with the standard method.\n\nSecondly, The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia, on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients (44%). Antibiotic therapy was ineffective for 30 patients (18%) and was therefore extended. It also enabled us to reduce the spectrum of antibiotic therapy, in particular through early oral relay, for 44 patients (26%).\n\nThe aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results, with significant consequences in terms of optimizing antibiotic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18\n* Patient hospitalized in a clinical department of each participating center\n* Patient managed in the context of bacteremia (microbiological criterion = positive blood culture)\n* Patient with positive blood culture for Enterobacterales\n* Patient affiliated to a health insurance scheme\n* Patient/relative having given free, informed and express oral consent\n\nExclusion Criteria:\n\n* Patients with non-enterobacterial bacteremia\n* Patient under guardianship\n* Patient deprived of liberty\n* Patient under court protection\n* Pregnant or breast-feeding patient'}, 'identificationModule': {'nctId': 'NCT06425367', 'acronym': 'MHR-Blood', 'briefTitle': 'Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Impact of Performing a Rapid Antibiotic Susceptibility Test (MHR-SIR) on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia, Controlled, Randomized Cluster and Cross-over Study', 'orgStudyIdInfo': {'id': '650-MHR Blood'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MHR SIR', 'description': 'rapid antibiotic susceptibility testing by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. Antibiotic susceptibility test results are obtained 7 hours after blood culture positivity', 'interventionNames': ['Diagnostic Test: Antibiotic susceptibility testing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MH', 'description': 'Standard antibiotic susceptibility testing by diffusion on MH (Mueller-Hinton ) medium from the blood culture bottle Antibiotic susceptibility test results are obtained 24 hours after blood culture positivity', 'interventionNames': ['Diagnostic Test: Antibiotic susceptibility testing']}], 'interventions': [{'name': 'Antibiotic susceptibility testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization', 'armGroupLabels': ['MH', 'MHR SIR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene BEAUSSIER', 'role': 'CONTACT', 'email': 'hbeaussier@ghpsj.fr', 'phone': '0144127038'}, {'name': 'Juliette COURTIADE MAHLER', 'role': 'CONTACT', 'email': 'jcourtiade@ghpsj.Fr', 'phone': '0144127963'}, {'name': 'Jean-claude NGUYEN VAN, pharmaD', 'role': 'CONTACT'}], 'facility': 'Hôpital Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Helene BEAUSSIER', 'role': 'CONTACT', 'email': 'crc@ghpsj.fr', 'phone': '+33144127038'}, {'name': 'Juliette COURTIADE MAHLER', 'role': 'CONTACT', 'email': 'jcourtiade@ghpsj.fr', 'phone': '+33144127963'}], 'overallOfficials': [{'name': 'Jean Claude NGUYEN VAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}