Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT07186894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cefazolin Versus Antistaphylococcal Penicillins for Methicillin Susceptible Staphylococcus Aureus Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90 days all-cause mortality', 'timeFrame': '90 days after the inclusion', 'description': 'All-cause mortality, at day 90'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality measured at other timeframes', 'timeFrame': 'day 7, day 30, and 1 year', 'description': 'All-cause mortality, at day 7, day 30, and 1 year'}, {'measure': 'Safety outcomes', 'timeFrame': '30 or 90 days after the inclusion', 'description': 'The definition of this event is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (published in November 27, 2017 by the U.S. department of health and human services)\n\nClostridioides difficile infection: Clostridioides difficile infection diagnosis, between one day and 90 days after the index event.\n\nNephrotoxicity: acute kidney injury diagnosis, between one day and 30 days after the index event.\n\nHepatotoxicity: hepatic failure or liver disease or elevation of liver enzymes, between one day and 30 days after the index event.\n\nAllergy: skin eruption or anaphylactic reaction, between one day and 30 days after the index event.\n\nHaematotoxicity: cytopenia or eosinophilia, between one day and 30 days after the index event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methicillin-susceptible Staphylococcus aureus', 'bacteremia', 'antistaphylococcal penicillins', 'cefazolin', 'real-word evaluation', 'TriNetX'], 'conditions': ['Bacteriemia', 'Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection']}, 'descriptionModule': {'briefSummary': 'Background Methicillin-susceptible Staphylococcus aureus (MSSA) bacteraemia is a common and serious infection, associated with significant morbidity and high mortality rates. Antistaphylococcal penicillins (ASPs) have traditionally been recommended as the first-line treatment. However, this established position has recently been challenged by meta-analyses suggesting that cefazolin may provide comparable efficacy, along with a more favourable safety profile. Further clinical and real-world studies are warranted to substantiate these findings.\n\nObjectives The aim of this study was to assess the effectiveness and safety of cefazolin compared with ASPs in the management of MSSA bacteraemia.', 'detailedDescription': 'Staphylococcus aureus (SA) is a frequent cause of bacteraemia and is associated with high mortality rates. Several studies have reported an increasing incidence over recent decades, accompanied by a decline in the prevalence of methicillin-resistant strains. In a recent meta-analysis by Bai et al., mortality related to S. aureus bacteraemia (SAB) remained substantial: 18.1% at one month, 27.0% at three months, and 30.2% at one year.\n\nIn the absence of specific international guidelines supported by randomised controlled trials, the management of methicillin-susceptible S. aureus (MSSA) bloodstream infections largely relies on expert consensus and clinical experience. For several decades, antistaphylococcal penicillins (ASPs) have been regarded as the gold standard for treating MSSA bacteraemia. This preference was primarily based on concerns regarding the so-called "inoculum effect," whereby the efficacy of cefazolin might be reduced at high bacterial loads .\n\nHowever, recurring global shortages of ASPs have led clinicians to consider cefazolin as a viable first-line alternative. In this context, several meta-analyses, albeit based on observational data, have suggested that cefazolin provides similar efficacy with a more favourable safety profile than ASPs . Nonetheless, these results remain subject to confounding and bias and must be confirmed through randomised controlled trials, two of which are currently ongoing.\n\nLarge, real-world evaluations are therefore needed to assess the comparative effectiveness and safety of cefazolin and ASPs in routine clinical settings. The TriNetX platform offers access to real-time, real-world global hospital data, thereby enabling large-scale comparative analyses in an international context. Against this background, the present study aimed to evaluate the effectiveness and tolerability of cefazolin versus ASPs in the treatment of MSSA bacteraemia using data from the TriNetX database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Variables : age, sex, medical history, type of infection and antibiotic used.\n\nVariables will be described as number and percentage for categorical variables, and mean and standard-deviation for continuous ones. A propensity score matching method will be conducted including (i) variables significantly different between the two cohorts in the bivariate descriptive analyses between the patient birth and the index event date (standard difference \\< 0.10 ; appendix 1), and (ii) clinically relevant variables (known confusion factors linked to mortality and safety outcomes ; appendix 2) at the index event date. Variables related to patients will be described before and after propensity score matching.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Monobacterial methicillin susceptible Staphylococcus aureus (MSSa) bacteremia\n* In the cefazolin group : Cefazolin injectable prescription in the week before or the week after MSSa bacteremia\n* In the ASPs group :ASPs injectable prescription (flucloxacillin, floxacillin, cloxacillin, oxacillin, nafcillin and dicloxacillin) in the week before or the week after MSSa bacteremia\n\nExclusion Criteria:\n\n* In the cefazolin group : ASP injectable prescription in the year before or the year after MSSa bacteremia\n* In the ASPs group : cefazolin injectable prescription in the year before or the year after MSSa bacteremia'}, 'identificationModule': {'nctId': 'NCT07186894', 'acronym': 'TriPasCef', 'briefTitle': 'Cefazolin Versus Antistaphylococcal Penicillins for Methicillin Susceptible Staphylococcus Aureus Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Effectiveness and Safety of Cefazolin Versus Antistaphylococcal Penicillins for Methicillin Susceptible Staphylococcus Aureus Bacteremia: a Multicentre Real-world Evaluation Using the International TriNetX Database', 'orgStudyIdInfo': {'id': 'TriPasCef'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antistaphylococcal penicillins (ASPs)', 'description': 'ASPs group\n\nInclusion criteria\n\n* Monobacterial methicillin susceptible Staphylococcus aureus (MSSa) bacteremia\n* Antistaphylococcal penicillins (ASPs) injectable prescription (flucloxacillin, floxacillin, cloxacillin, oxacillin, nafcillin and dicloxacillin) in the week before or the week after MSSa bacteremia\n\nExclusion criteria : cefazolin injectable prescription in the year before or the year after MSSa bacteremia', 'interventionNames': ['Drug: Antistaphylococcal penicillins']}, {'label': 'Cefazolin', 'description': 'Cefazolin group\n\nInclusion criteria\n\n* Monobacterial methicillin susceptible Staphylococcus aureus (MSSa) bacteremia\n* Cefazolin injectable prescription in the week before or the week after MSSa bacteremia\n\nExclusion criteria : ASP injectable prescription in the year before or the year after MSSa bacteremia', 'interventionNames': ['Drug: Cefazolin']}], 'interventions': [{'name': 'Antistaphylococcal penicillins', 'type': 'DRUG', 'description': 'It in not an interventional study. This project is a phase IV, retrospective, descriptive, and multicentric study.', 'armGroupLabels': ['Antistaphylococcal penicillins (ASPs)']}, {'name': 'Cefazolin', 'type': 'DRUG', 'description': 'It in not an interventional study. This project is a phase IV, retrospective, descriptive, and multicentric study.', 'armGroupLabels': ['Cefazolin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data are available upon reasonable request. Researchers can request access to data from the TriNetX research network through the TriNetX platform (https://live.trinetx.com). However, this may involve associated costs, require a data-sharing agreement and no patient-identifiable information can be accessible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor (MD PhD)', 'investigatorFullName': 'LEFEVRE Benjamin', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}