[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06637904":3,"trial-entities:NCT06637904":119,"trial-summary:NCT06637904":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":46,"sex":64,"minimum_age":65,"maximum_age":16,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":111,"overall_officials":116,"references":117,"see_also_links":118},"NCT06637904","INF-29","TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections","RECRUITING","2025-03-31","2025-01","2025-01-08","2024-11-08","Inflammatix","INDUSTRY",true,"A pre\u002Fpost interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and\u002For the staging area\u002Ffast track area) with suspected infection and tachycardia or fever will be enrolled. Study conduct will be performed under an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching, whereas participants in the post-phase will be managed incorporating the TriVerity™ Acute Infection and Sepsis Test results with standardized guidance for interpretation and resulting management actions. Many outcomes will be captured and compared between the pre- and post-phase phases including sepsis bundle compliance, patient disposition, appropriate use of antimicrobials (antibiotics and antivirals) and health economic findings. Safety measures for participants in the post-phase will include patient follow-up at predefined time points. The objective is to demonstrate improvement of patient management when incorporating the TriVerity Test result compared to standard of care. Improvements based on diagnostic (bacterial vs viral vs non-infectious inflammation) and prognostic (need for 7-day ICU level care) readouts of the TriVerity Test result will be tracked.",null,[18,19,20,21],"Sepsis","Infections","Tachycardia","Fever",[],"INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},300,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","TriVerity Test","Participants in the post-phase of the study will have a 2.5 ml whole blood draw obtained via venipuncture into a PAXgene® Blood RNA tube. Blood samples will be processed using the TriVerity Cartridge on the Myrna Instrument located in the ED.",[36],"Post-phase TriVerity Test",[38,42],{"measure":39,"description":40,"timeFrame":41},"SEP-1 bundle compliance","Mandatory hospital procedures for patients admitted with suspected sepsis","Within 72 hours of ED admission",{"measure":43,"description":44,"timeFrame":45},"Time to final ED disposition order","Time from Triage (on Day 0) to the Time the ED physician orders the subject disposition (i.e., where the subject will go next: admittance or discharge).","Date of enrollment (Day 0) to final Follow Up call (up to 35 days)",[47,50,53,57,60],{"measure":48,"description":49,"timeFrame":45},"Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes","Calculated based on number of patients given antibiotics in ED",{"measure":51,"description":52,"timeFrame":45},"Emergency Department LOS","Length of Stay",{"measure":54,"description":55,"timeFrame":56},"Diagnostic ordering practices","Capturing the diagnostic ordering practices of attending physician (comparing physician choices and decisions before and after the TriVerity Test)","Date of enrollment (Day 0) to 72 hours",{"measure":58,"description":59,"timeFrame":56},"Hospital admission rates","Overall admission rates for patients that meet study criteria from emergency department to other location (e.g., ICU)",{"measure":61,"description":62,"timeFrame":63},"Total hospital costs","Overall hospital costs for patients that meet study criteria","Date of enrollment (Day 0) to 28 days","ALL","18 Years",false,{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"Inclusion Criteria:\n\n1. Age ≥18 years\n2. Participant presents to ED with ALL of the below:\n\n   2.1. Suspected acute infection (e.g., respiratory, urinary, abdominal, skin \\& soft-tissue infection, meningitis\u002Fencephalitis, or any other infection), and 2.2. Either heart rate \\>100 beats per minute or\u002Fand temperature \\>38C. 2.3. NOT immediately roomed in a primary designated treatment location,( i.e., they can be in the waiting room, ED triage hallways, and\u002For ED staging area\u002Ffast track area).\n3. Able to provide informed consent, or consent by legally authorized representative.\n4. Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).\n\nExclusion Criteria:\n\n1. Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to presentation in the waiting room of the ED. Participants will not be excluded for use of:\n\n   1. Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C\n   2. Topical antibiotics, topical antivirals or topical antifungal agents\n   3. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection\n   4. Single dose of one or combination of peri-operative (prophylactic) antibiotics\n2. Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).\n3. Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.\n4. Participants receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. Participants that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.\n5. Participants previously enrolled in the present clinical trial.",[72,73],"ADULT","OLDER_ADULT",[75,94],{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":91},"OSF HealthCare Saint Francis Medical Center","Peoria","Illinois","61637","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Dawn R Bolliger","CONTACT","815-848-2075","dawn.r.bolliger@osfhealthcare.org",{"name":88,"role":84,"phone":89,"email":90},"Abhigna C Madineni","309-624-2410","abhigna.c.madineni@osfhealthcare.org",{"lat":92,"lon":93},40.69365,-89.58899,{"facility":95,"status":7,"city":96,"state":97,"zip":98,"country":80,"contacts":99,"geoPoint":108},"Johns Hopkins Department of Emergency Medicine","Baltimore","Maryland","21287",[100,104],{"name":101,"role":84,"phone":102,"email":103},"Breana McBryde","443-812-8757","bmcbryd1@jhmi.edu",{"name":105,"role":84,"phone":106,"email":107},"Gaby Dashler","717-487-2060","ggladfe1@jhmi.edu",{"lat":109,"lon":110},39.29038,-76.61219,[112],{"name":113,"role":84,"phone":114,"email":115},"Shailee Rasania","862-295-8740","srasania@inflammatix.com",[],[],[],{"nct_id":4,"conditions":120,"biomarkers":123},[21,121,122,20],"Infection","Septicemia",[],{"nct_id":4,"found":14,"summary":125,"prompt_version":135},{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This study is an interventional trial involving 300 participants. It compares standard care to care that includes the TriVerity™ test results.","completed","TriVerity™ for Suspected Infections in the Emergency Department","This study is looking at how a new diagnostic test, TriVerity™, can help doctors manage patients with suspected infections in the Emergency Department (ED). You might be eligible if you are 18 or older, come to the ED with a suspected infection (like a respiratory or skin infection), and also have a fast heart rate (over 100 beats per minute) or a fever (over 38 degrees Celsius). The study aims to see if using the TriVerity™ test can improve how quickly patients receive appropriate care for their infection and how fast they are discharged from the ED. The study is comparing standard care to care that includes the TriVerity™ test results.","Your progress will be followed from the date of enrollment up to 35 days.",111,"If you are in the 'post-phase' of the study, you will have a 2.5 ml blood draw. The blood sample will be processed using the TriVerity Cartridge on the Myrna Instrument.","Not stated in the trial record.",[],"v2"]