Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 8:17 AM
Study NCT ID:
NCT04999592
Status:
TERMINATED
Last Update Posted:
2025-04-17
First Post:
2021-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)
Sponsor:
Organization:
Raw JSON
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Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days.\n\nAntibiotic prophylaxis: Ceftriaxone 2 gm IV q12h for 3 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '65'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '67'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '53 subjects were consented and 1 withdrew consent leaving 52 subjects (26 in each arm) evaluable.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-19', 'size': 1237754, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-05T08:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The clinical team responsible for the participant (physicians, nurses and others) and involved with direct patient care will be blinded. Investigators will be blinded and the placebo will match the study drug. Outcomes Assessors will be blinded to treatment assignment during assessments of pneumonia and functional outcome.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'Lapse in funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2021-07-08', 'resultsFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-16', 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically-diagnosed Early-onset Pneumonia', 'timeFrame': '4 days', 'description': 'Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia occurring \\<4 days after initiation of mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'Microbiologically-confirmed Early-onset Pneumonia', 'timeFrame': '4 days', 'description': 'Percentage of Participants with Microbiologically-confirmed Early-onset Pneumonia occurring \\<4 days after initiation of mechanical ventilation'}, {'measure': 'Microbiologically-confirmed Late-onset Pneumonia', 'timeFrame': '≥ 4 days', 'description': 'Percentage of Participants with Microbiologically-confirmed late-onset pneumonia occurring ≥4 days after initiation of mechanical ventilation'}, {'measure': 'Clinically-diagnosed Late-onset Pneumonia', 'timeFrame': '≥ 4 days', 'description': 'Percentage of Participants with Clinically-diagnosed late-onset pneumonia occurring ≥4 days after initiation of mechanical ventilation'}, {'measure': 'Non-pulmonary Infections', 'timeFrame': 'During the intervention and immediately after the intervention until hospital discharge, up to 6 months', 'description': 'Percentage of Participants with non-pulmonary infections'}, {'measure': 'ICU-free Days During Admission', 'timeFrame': '28 days', 'description': 'ICU-free days in the first 28 days of admission'}, {'measure': 'Mechanical Ventilator-free Days During Admission', 'timeFrame': '28 days', 'description': 'Mechanical ventilator-free days in the first 28 days of admission'}, {'measure': 'Death in the Hospital', 'timeFrame': 'During the intervention (3 days) and immediately after the intervention until subject death or hospital discharge, an average of 30 days', 'description': 'Percentage of Participants who Die in the Hospital during admission'}, {'measure': 'Functional Outcome at 6 Months Post-hospital Discharge', 'timeFrame': '6 months post-hospital discharge', 'description': 'Median mRS (0 as no residual symptoms and 6 as death) at 6 Months Post-hospital Discharge'}, {'measure': 'Clostridioides Difficile-associated Diarrhea', 'timeFrame': 'During the intervention and immediately after the intervention until death or hospital discharge', 'description': 'Percentage of Participants with Clostridioides difficile-associated Diarrhea'}, {'measure': 'Type One Hypersensitivity Reactions', 'timeFrame': 'Three days', 'description': 'Percentage of Participants with Type One (immediate-type) hypersensitivity reactions'}, {'measure': 'Participants With Gallbladder Disease', 'timeFrame': 'During the intervention and immediately after the intervention until death or hospital discharge', 'description': 'Percentage of Participants with Gallbladder disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['out-of-hospital cardiac arrest', 'cardiac arrest', 'pneumonia', 'randomized clinical trial', 'infection', 'ceftriaxone', 'microbiome', 'inflammation', 'prophylaxis'], 'conditions': ['Out-Of-Hospital Cardiac Arrest', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '35246202', 'type': 'BACKGROUND', 'citation': 'Gagnon DJ, Ryzhov SV, May MA, Riker RR, Geller B, May TL, Bockian S, deKay JT, Eldridge A, Van der Kloot T, Lerwick P, Lord C, Lucas FL, Mailloux P, McCrum B, Searight M, Wirth J, Zuckerman J, Sawyer D, Seder DB. Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial. Trials. 2022 Mar 4;23(1):197. doi: 10.1186/s13063-022-06127-w.'}, {'pmid': '40885534', 'type': 'DERIVED', 'citation': 'Gagnon DJ, Burkholder KM, Weissman AJ, Riker RR, Ryzhov S, May TL, DiPalazzo J, deKay JT, Knudsen L, Moore MW, Pozzessere NA, Weatherbee M, Kelly M, Nigatu AS, Sevigny JL, Simpson S, Thomas WK, Callaway CW, Geller BJ, Sawyer DB, Seder DB. Ceftriaxone to Prevent Early-Onset Pneumonia in Comatose Patients Following Out-of-Hospital Cardiac Arrest: A Pilot Randomized Controlled Trial and Resistome Assessment (PROTECT). Chest. 2025 Aug 28:S0012-3692(25)05134-7. doi: 10.1016/j.chest.2025.08.007. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Randomized-controlled trial and microbiome assessment to understand the risk-to-benefit ratio of prophylactic antibiotics (Ceftriaxone) vs placebo in patients with pneumonia and inflammation after cardiac arrest outside the hospital.', 'detailedDescription': 'Pneumonia is an infection of the lungs resulting in alveolar inflammation and fluid or purulent material accumulation. It is the most common infection after cardiac arrest occurring in up to 65% of patients treated with targeted temperature management. Pneumonia may result from aspiration during cardiopulmonary resuscitation (CPR), or by introduction of oropharyngeal flora into the lungs during airway management. Preventing infection after OHCA may: 1) reduce exposure to broad-spectrum antibiotics and subsequent collateral damage, 2) prevent hemodynamic derangements due to local and systemic inflammation, and 3) prevent an association between infection and morbidity and mortality. These benefits must be balanced with the risk for altering bacterial resistomes in the absence clinical infection. Accordingly, further study is warranted to understand the risk-to-benefit ratio of prophylactic antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Comatose (do not follow simple verbal commands)\n* Have any initial heart rhythm (shockable or non-shockable)\n* OHCA including the emergency department\n\nExclusion Criteria:\n\n* Name on opt-out list\n* In-hospital cardiac arrest\n* Interval \\>6 hours from ICU admission to study drug receipt\n* Preexisting terminal disease making 180-day survival unlikely\n* Refused informed consent\n* Emergent coronary artery bypass grafting\n* Anaphylaxis or angioedema to beta-lactam antibiotics (i.e., cephalosporins or penicillins)\n* Under legal guardianship or prisoner\n* Known colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococcus (VRE)\n* Clinical bacterial infection prior to hospital admission defined as any one of the following:\n\n * Infectious prodrome preceding OHCA\n * Active course of antibiotics for infection prior to admission\n * Active infection documented in the electronic medical record\n * Family or surrogate endorsement of an active infection'}, 'identificationModule': {'nctId': 'NCT04999592', 'acronym': 'PROTECT', 'briefTitle': 'Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT): a Randomized-controlled Trial and Microbiome Assessment', 'orgStudyIdInfo': {'id': '1P20GM139745-01', 'link': 'https://reporter.nih.gov/quickSearch/1P20GM139745-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P20GM139745', 'link': 'https://reporter.nih.gov/quickSearch/P20GM139745', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No prophylaxis (placebo)', 'description': 'Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted.\n\nAdminister antibiotics in response to infection.', 'interventionNames': ['Drug: Standard of care without prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Prophylaxis', 'description': 'Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days.', 'interventionNames': ['Drug: Antibiotic prophylaxis']}], 'interventions': [{'name': 'Standard of care without prophylaxis', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Administer antibiotics in response to infection', 'armGroupLabels': ['No prophylaxis (placebo)']}, {'name': 'Antibiotic prophylaxis', 'type': 'DRUG', 'otherNames': ['Rocephin (ceftriaxone)'], 'description': 'Ceftriaxone 2 gm IV q12h for 3 days', 'armGroupLabels': ['Prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'overallOfficials': [{'name': 'David Gagnon, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MaineHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David J. Gagnon', 'class': 'OTHER'}, 'collaborators': [{'name': 'MaineHealth', 'class': 'OTHER'}, {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, {'name': 'University of New England', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Critical Care Clinical Pharmacist', 'investigatorFullName': 'David J. Gagnon', 'investigatorAffiliation': 'MaineHealth'}}}}