Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-01 @ 6:48 AM
Study NCT ID:
NCT04158804
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2019-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkmansour@mgb.org', 'phone': '617-726-6726', 'title': 'Michael K. Mansour, MD, Ph.D.', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected starting at enrollment day until 30 days after enrollment.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.', 'otherNumAtRisk': 357, 'deathsNumAtRisk': 357, 'otherNumAffected': 0, 'seriousNumAtRisk': 357, 'deathsNumAffected': 19, 'seriousNumAffected': 76}, {'id': 'EG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 0, 'seriousNumAtRisk': 343, 'deathsNumAffected': 17, 'seriousNumAffected': 81}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical Ventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 57, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Short Treatment of Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'OG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite Safety Adverse Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'OG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Composite endpoints include: all-cause in-hospital mortality, all-cause mortality after discharge (as available), hospital readmission, septic shock (vasopressor use for \\> 1 hour), mechanical ventilation (via endotracheal tube), required dialysis, lung abscess/empyema/cavitation/necrotizing pneumonia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibiotic Exposure at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'OG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'Duration of antibiotics prescribed at discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Therapy Per 1000 Patient Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'OG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '2.67'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'Days of therapy per 1000 patient days (inclusive of antibiotics prescribed at discharge)', 'unitOfMeasure': 'Days of Therapy Per 1000 Patient Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'OG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days', 'description': 'Length of stay in hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'OG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of Participants Admitted to the ICU', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clostridium Difficile Infection (CDI)', 'timeFrame': '30 days', 'description': 'Treatment or readmission for CDI until day 30 after enrollment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Economic Endpoints', 'timeFrame': '30 days', 'description': 'Costs associated with primary hospitalization, readmission for CDI, and loss of function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'FG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '357'}, {'groupId': 'FG001', 'numSubjects': '343'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '357'}, {'groupId': 'FG001', 'numSubjects': '343'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '700', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care (SOC)', 'description': 'PCT results were hidden from the medical record and no ASP recommendation given.'}, {'id': 'BG001', 'title': 'PCT/ASP', 'description': 'PCT results were posted in the medical record and ASP emailed recommendation to the medical team.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '84'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '81'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '608', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pneumonia Type', 'classes': [{'categories': [{'title': 'CAP (community-acquired pneumonia)', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'HCAP (healthcare-associated pneumonia)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Aspiration', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pneumonia Severity Index (PSI)', 'classes': [{'categories': [{'title': 'Class I (lowest severity)', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Class II', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Class III', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Class IV', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Class V (highest severity)', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Pneumonia Severity Index is a clinical tool used to assess the severity of pneumonia based on several clinical factors, including demographics, comorbidities, physical exam findings, vital signs, and lab and imaging results.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-08', 'size': 1251670, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-09T11:38', 'hasProtocol': True}, {'date': '2023-06-12', 'size': 858334, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-09T11:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2019-11-07', 'resultsFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-04', 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clostridium Difficile Infection (CDI)', 'timeFrame': '30 days', 'description': 'Treatment or readmission for CDI until day 30 after enrollment'}, {'measure': 'Healthcare Economic Endpoints', 'timeFrame': '30 days', 'description': 'Costs associated with primary hospitalization, readmission for CDI, and loss of function'}], 'primaryOutcomes': [{'measure': 'Short Treatment of Pneumonia', 'timeFrame': '30 days', 'description': 'Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")'}], 'secondaryOutcomes': [{'measure': 'Composite Safety Adverse Event Rate', 'timeFrame': '30 days', 'description': 'Composite endpoints include: all-cause in-hospital mortality, all-cause mortality after discharge (as available), hospital readmission, septic shock (vasopressor use for \\> 1 hour), mechanical ventilation (via endotracheal tube), required dialysis, lung abscess/empyema/cavitation/necrotizing pneumonia'}, {'measure': 'Antibiotic Exposure at Discharge', 'timeFrame': '30 days', 'description': 'Duration of antibiotics prescribed at discharge'}, {'measure': 'Days of Therapy Per 1000 Patient Days', 'timeFrame': '30 days', 'description': 'Days of therapy per 1000 patient days (inclusive of antibiotics prescribed at discharge)'}, {'measure': 'Length of Stay', 'timeFrame': '30 days', 'description': 'Length of stay in hospital'}, {'measure': 'ICU Admissions', 'timeFrame': '30 days', 'description': 'Number of Participants Admitted to the ICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pneumonia, Bacterial']}, 'descriptionModule': {'briefSummary': 'Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Despite this strong evidence from multiple studies a recent prospective multicentric interventional trial in the US fell short of demonstrating antibiotic reductions by PCT-guided antibiotic management. Amongst other limitations the authors of that study concluded that successful implementation of PCT may require closer educational oversight. As such, this study will compare effectiveness and safety of antibiotic prescription guided by a PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients with suspected or confirmed LRTI (including sepsis with respiratory focus).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized adult patients ≥ 18 years of age\n* Suspected or confirmed pneumonia \\<28 days at time of admission to the hospital (ED) who are prescribed antibiotics\n* Minimum of 2 (two) blood samples available for PCT value assessment within 24 hours of hospitalization\n\nExclusion Criteria:\n\n* Patient has tested positive for SARS-CoV-2\n* Non-hospitalized patients\n* Patients admitted to home health\n* Major surgeries, defined as any procedure in which an incision is made with the exception of superficial procedures (eyes, cornea, skin, dental procedures), organs removed, or normal anatomy altered (e.g. open thoracic, abdominal and/or major orthopedic surgery), in the past 1 month or expected surgical procedure or patient receiving antibiotics for surgical prophylaxis\n* Active metastatic cancer or neuroendocrine tumor or liquid tumor and/or on check point inhibitors within 3 months or has signs of mucositis (e.g. mouth lesions or intestinal bleeding)\n* Known pregnancy\n* Primary and acquired cell-mediated immune deficiency (HIV with CD4 \\<350 cells/mm³; receipt of systemic chemotherapy and/or biologics in the past 3 months for reasons other than malignancy)\n* Infection where long course antibiotics are the standard of care(\\>2 weeks) other than anti-inflammatory reasons.\n* Neutropenia (\\<1,500 ANC)\n* Concomitant non-pulmonary bacterial infection that requires antibiotic therapy based on an active medical team decision\n* Antibiotics given for non-infectious indications (e.g. rifaximin for hepatic encephalopathy)\n* Patients with cystic fibrosis\n* Patients receiving dialysis\n* Patients with solid organ transplant, bone marrow transplant or stem cell transplant recipient\n* ST elevation myocardial infarction\n* Prior enrollment into this study within 30 days\n* Patient experiencing major trauma defined as any injury that could cause prolonged disability and/or an Injury Severity Score \\>15, and/or burns or patient under extracorporeal circulation confirmed by a second research staff member.\n* Patient with acute viral hepatitis and/or decompensated severe liver cirrhosis (Child-Pugh Class C).\n* Patient with prolonged or severe cardiogenic shock, defined as decreased cardiac output leading to end organ injury (e.g. severe hypotension or AKI or oliguria or altered mental status or cool extremities or respiratory distress AND evidence of metabolic acidosis on lab testing)\n* Patient with pancreatitis, chemical pneumonitis or heat stroke\n* Active infection with invasive fungal pathogen (e.g. candidiasis, aspergillosis) or plasmodium falciparum malaria or mycobacteria\n* Patient under treatment with OKT3 antibodies, OK-432, interleukins, TNF-alpha and other drugs stimulating the release of pro-inflammatory cytokines or resulting in anaphylaxis.\n* Patient is under hospice care\n* Patient with ventilator associated pneumonia\n* Patients with untreated, active, and symptomatic autoimmune disease\n* Patients with empyema, abscess, or cavitary/necrotizing pneumonia\n* Patients actively enrolled in other clinical trial involving immunomodulatory therapy'}, 'identificationModule': {'nctId': 'NCT04158804', 'acronym': 'ProSAVE', 'briefTitle': 'PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs', 'orgStudyIdInfo': {'id': '2019P000362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procalcitonin algorithm+stewardship team', 'description': 'antibiotic prescription guided by PCT values', 'interventionNames': ['Diagnostic Test: procalcitonin']}, {'type': 'NO_INTERVENTION', 'label': 'standard group', 'description': 'standard of care guided by current guidelines'}], 'interventions': [{'name': 'procalcitonin', 'type': 'DIAGNOSTIC_TEST', 'description': 'accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection', 'armGroupLabels': ['Procalcitonin algorithm+stewardship team']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06790', 'city': 'Torrington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Charlotte Hungerford Hospital', 'geoPoint': {'lat': 41.80065, 'lon': -73.12122}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02557', 'city': 'Oak Bluffs', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Martha's Vineyard Hospital", 'geoPoint': {'lat': 41.45428, 'lon': -70.56197}}, {'zip': '01970', 'city': 'Salem', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'North Shore Medical Center', 'geoPoint': {'lat': 42.51977, 'lon': -70.89552}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Harris Methodist Hospital', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Michael K Mansour, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'BRAHMS GmbH', 'class': 'UNKNOWN'}, {'name': 'Thermo Fisher Scientific, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Michael K. Mansour', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}