Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:44 PM
Study NCT ID:
NCT07450404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with PK/PD target attainment', 'timeFrame': '24 hours', 'description': 'Proportion of patients with serum concentrations of CEFTRIAXONE above the minimal inhibitory concentration (MIC) of 4 mg/mL (in case of undocumented VAP), or \\> 4 times the MIC of documented bacteria.'}], 'secondaryOutcomes': [{'measure': 'Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae', 'timeFrame': 'Day 7'}, {'measure': 'Association between augmented renal clearance and PK/PD target attainment', 'timeFrame': '24 hours'}, {'measure': 'Association between hyperbilirubinemia and PK/PD target attainment', 'timeFrame': '24 hours'}, {'measure': 'Association between PK/PD target attainment and day 28 mortality', 'timeFrame': 'Day 28'}, {'measure': 'Association between PK/PD target attainment and ICU length of stay', 'timeFrame': '3 months'}, {'measure': 'Incidence of multi drug resistance bacteria', 'timeFrame': 'Day 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibiotic prophylaxis', 'ventilator associated pneumonia', 'augmented renal clearance', 'PK/PD target attainment'], 'conditions': ['Early Ventilator Associated Pneumonia', 'Acute Brain Injuries']}, 'descriptionModule': {'briefSummary': 'Critically ill patients admitted for acute brain injury are exposed to many heath-care associated infections such as ventilator associated pneumoniae (VAP). The PROHYVAP study, published in 2024 reported that a single dose of CEFTRIAXONE as an antibiotic prophylaxis could reduce the incidence of early VAP (VAP that occured between day 2 and day 7 of mechanical ventilation).\n\nHowever, patients with acute brain injury also presented frequently augmented renal clearance (ARC), which could affect the pharmacokinetic and pharmacodynamic target attainment (PK/PD) of antibiotic prophylaxis.\n\nThis study aims to analyse the PK/PD target attainment after one dose of CEFTRIAXONE in critically ill patients with acute brain injury and to describe the effect of ARC on PK/PD target attainment during early VAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted in intensive care unit for an acute brain injury caused by a traumatic brain injury or a vascular cerebral disease (ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage) with a Glasgow coma scale \\< 12 and needed a mechanical ventilation for 48 hours or more, started in the first 12 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Admitted in intensive care unit for acute brain injury, including traumatic brain injury and cerebral vascular disease\n* Glasgow coma scale inferior to 12\n* Orotracheal intubation in first 12 hours of admission\n* Needed of invasive mechanical ventilation for at least 48 hours\n\nExclusion Criteria:\n\n* Acute brain injury related to tumoral or infectious process\n* Antibiotic therapy administered before acute brain injury for an other pathology\n* Patients with a risk of multiresistance bacteria contamination (stay in a risk area in the past 3 months, antibiotic therapy with fluoroquinolone or betalctamine in the past 3 months, hospitalization in last month before admission, documented contaminationwith multiresistance bacteria, immunodepression)\n* Patients with hish risk of death in the first 48 hours\n* Patients with a beta-lactams reported allergy'}, 'identificationModule': {'nctId': 'NCT07450404', 'acronym': 'NeuroPKVAP', 'briefTitle': 'PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients', 'orgStudyIdInfo': {'id': '2025PI164'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients with acute brain injury', 'description': 'Patients with severe acute brain injury defined by a Glasgow coma scale \\< or = 8, admitted to the intensive care unit and needed invasive mechanical ventilation for at least 48 hours.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'CHRU de Nancy - Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '54000', 'city': 'Nancy', 'state': 'Meurthe-et-Moselle', 'country': 'France', 'contacts': [{'name': 'Maureen STEIB', 'role': 'CONTACT', 'email': 'm.steib@chru-nancy.fr', 'phone': '+33 3 83 85 10 45'}, {'name': 'Viviane MARTIN, PhD', 'role': 'CONTACT', 'email': 'v.martin3@chru-nancy.fr'}], 'facility': 'CHRU Nancy - Hopital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Maureen Steib, MD', 'role': 'CONTACT', 'email': 'm.steib@chru-nancy.fr', 'phone': '+33 3 83 85 10 45'}], 'overallOfficials': [{'name': 'Emmanuel NOVY, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistante Spécialiste', 'investigatorFullName': 'STEIB Maureen', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}