Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-27 @ 9:36 PM
Study NCT ID:
NCT06766461
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 980}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': 'From enrollment to 28 days'}], 'secondaryOutcomes': [{'measure': '90-day mortality', 'timeFrame': 'From enrollment to 90 days'}, {'measure': '365-day mortality', 'timeFrame': 'From enrollment to the 365 days'}, {'measure': 'ICU lengt of stay', 'timeFrame': 'From enrollment to the end of the study period at 12 months'}, {'measure': 'Hospital lengt of stay', 'timeFrame': 'From enrollment to the end of the study period at 12 months'}, {'measure': 'Time to shock reversal', 'timeFrame': 'From enrollment to the end of the study period at 12 months', 'description': 'From enrollment to the use of \\<0.1 gamma of vasopressors for 4 consecutive hours.'}, {'measure': 'Microbiological eradication', 'timeFrame': 'From enrollment to hospital discharge', 'description': 'Eradication of the causative organism from the primary source up to 30 days after therapy when confirmed by at least one repeated culture. In cases where there were no repeat cultures and the patient had resolution of the infection, microbial eradication will be presumed.'}, {'measure': 'Clinical cure', 'timeFrame': 'From enrollment to 14 days', 'description': 'Completion of β-lactam antibiotic by day 14 without recommencement of antibiotics within 48hrs of cessation for same infective episode (investigator assessment of clinical response)'}, {'measure': 'Plasma concentrations of the beta-lactam antibiotics', 'timeFrame': 'From enrollment to day 3', 'description': 'Through concentrations take once a day for 3 consectutive days after enrollment. Target attianment is defined as 100%fT\\>4xMIC'}, {'measure': 'Delta SOFA', 'timeFrame': 'From enrollment to day 3', 'description': 'SOFA at day 3 - SOFA at admission'}, {'measure': 'Delta Lactate', 'timeFrame': 'From enrollment to day 3', 'description': 'Lactate at day 3 - lactate upon inclusion'}, {'measure': 'Quality of life', 'timeFrame': '3 and 12 months after inclusion', 'description': 'EQ-5D-5L, a quetionnaire scoring 1 to 5 points on 5 domains. A higher score means a worse outcome.'}, {'measure': 'Medical consumption', 'timeFrame': '3 and 12 months after inclusion', 'description': 'iMTA Medical Consumption questionnaire'}, {'measure': 'Productivity', 'timeFrame': '3 and 12 months after inclusion', 'description': 'iMTA Productivity questionnaire'}, {'measure': 'Adverse events and toxicity', 'timeFrame': 'From enrollment until the end of the study period at 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'intensive care', 'critically ill', 'antibiotic', 'septic shock'], 'conditions': ['Sepsis - to Reduce Mortality in the Intensive Care Unit', 'Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '40119275', 'type': 'DERIVED', 'citation': 'Horstink MMB, Geel DR, Uil CAD, Deetman PE, Endeman H, Abdulla A, Bosch TM, Rietdijk WJR, Thielen FW, Haringman JJ, van Vliet P, Rijpstra TA, Bethlehem C, Beishuizen A, Muller AE, Koch BCP; BULLSEYE investigators. Standard versus double dosing of beta-lactam antibiotics in critically ill patients with sepsis: The BULLSEYE study protocol for a multicenter randomized controlled trial. BMC Infect Dis. 2025 Mar 21;25(1):392. doi: 10.1186/s12879-025-10747-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate if an initial short double dose of beta-lactam antibiotics will reduce mortality in critically ill patients with sepsis.', 'detailedDescription': 'Objective\n\nTo determine if using higher dosages of beta-lactam antibiotics in the initial phase of sepsis improves clinical outcome of critically ill patients.\n\nMain trial endpoints\n\nThe main trial endpoint is all cause 28-day mortality.\n\nSecondary trial endpoints\n\nSecondary trial endpoints include: Hospital length of stay, ICU length of stay, microbiological eradication, time to shock reversal, clinical cure, Δ Lactate, Δ PCT, Δ SOFA, 90- day mortality, 365-day mortality, pharmacodynamic target, post study calculation of the costs in both study, groups, EQ5D questionnaire 3 and 12 months after Admission, iMTA productivity questionnaire 3 and 12 months after admission, iMTA medical consumption questionnaire 3 and 12 months after admission and the number of adverse events.\n\nTrial design\n\nThis is an open label, randomized controlled trial.\n\nTrial population\n\nThe trial population will consist of adult patients admitted to the intensive care department with sepsis who will be treated according to protocol with beta-lactam antibiotics.\n\nInterventions\n\nDuring the trial participants in the intervention group will receive a double dose of antibiotics for the first 48 hours in comparison to the standard dose in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics)\n* Primary infection\n* Admitted to the ICU\n* Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mmHg or greater, and a serum lac tate level greater than 2.0 mmol/L following "adequate fluid resuscitation".\n\nExclusion Criteria:\n\n* Patient or legal representative not available to give informed consent within 72 hours after admittance\n* Pregnancy\n* Admittance for burn wounds\n* Patients receiving target antibiotics only as prophylaxis within the context of Selective Diges tive tract Decontamination (SDD)\n* Enrolment in another interventional trial\n* Patient received the study antibiotic for more than 24 hours before inclusion\n* Patient receiving extracorporeal membrane oxygenation (ECMO)\n* Patient is already treated with a double dose of antibiotics based on suspected infection'}, 'identificationModule': {'nctId': 'NCT06766461', 'acronym': 'BULLSEYE', 'briefTitle': 'Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis', 'orgStudyIdInfo': {'id': '2024-512950-13'}, 'secondaryIdInfos': [{'id': '10140022310046', 'type': 'OTHER_GRANT', 'domain': 'ZonMW'}, {'id': '2024-512950-13-00', 'type': 'CTIS'}, {'id': 'U1111-1308-9223', 'type': 'REGISTRY', 'domain': 'WHO universal trial number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This arm will receive standard of care according to local protocol.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This arm will be treated with double dosages of beta-lactam antibiotics the first 48 hours after inclusion.', 'interventionNames': ['Drug: Double dosing of beta-lactam antibiotic']}], 'interventions': [{'name': 'Double dosing of beta-lactam antibiotic', 'type': 'DRUG', 'description': 'This arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dr. Den Uil', 'role': 'CONTACT', 'email': 'uilc@maasstadziekenhuis.nl', 'phone': '0031102913474'}], 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Birgit C.P. Koch, PharmD', 'role': 'CONTACT', 'email': 'b.koch@erasmusmc.nl', 'phone': '0031107033202'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maasstad Hospital', 'class': 'OTHER'}, {'name': 'Albert Schweitzer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Birgit Koch', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}