Clinical trials: SIRS, open to volunteers
Sepsis, Septic Shock
ARTICE® Real Data Collection & Observational Trial, Phase 4 Study
The objectives of this registry study are to: 1. Record real-life data related to the use of the ARTICE® therapy in sepsis subjects. 2. Further evaluate ARTICE® treatment efficacy. 3.
- Conditions
- Sepsis, Septic Shock, Immunoparalysis in Septic Shock
- Trial name
- ARTistry (NCT07388628)
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Artcline GmbH
Sepsis, Respiratory Failure
Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of…
- Trial name
- NUC-CAP (NCT05647096)
- Testing
- NucleoCapture device
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 73 people
- Sponsor
- Santersus AG
Sepsis, Community Acquired Pneumonia (CAP)
OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
OPT101-100-40 is a multicenter, randomized, placebo-controlled, multiple-ascending-dose, sequential-group, investigator- and participant-blinded, sponsor-unblinded, study of OPT101 vs placebo when administered for up to 4 days to…
- Trial name
- NCT06669403
- Testing
- OPT101
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Op-T LLC
Sepsis
Performance and Impact of the Sepsis ImmunoScore
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
- Trial name
- NCT07543497
- Testing
- Sepsis ImmunoScore
- Volunteers
- 5,000 people
- Sponsor
- Prenosis, Inc.
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
Biomarkers, Acute Kidney Injury
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
The goal of this observational study is to understand whether a wearable sensor (the Nutromics Sensor Device) can accurately measure drug and biomarker levels in the fluid just under the skin (interstitial fluid), instead of…
- Conditions
- Biomarkers, Acute Kidney Injury, Sepsis
- Trial name
- VENTURE (NCT07893223)
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Nutromics
Sepsis, Severe
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care.
- Trial name
- ReActiF-ICE (NCT05442710)
- Testing
- ARTICE
- Where
- 20 sites in Germany
- Volunteers
- 142 people
- Sponsor
- Artcline GmbH
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Sepsis, Septic Shock
NAI for Sepsis With Persistent Lymphopenia
This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with…
- Conditions
- Sepsis, Septic Shock, Lymphopenia, Immunosuppression
- Trial name
- NCT07578558
- Testing
- Nogapendekin alfa inbakicept (NAI), Standard of Care (SOC)
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Middle East Study of Infections in Patients With Hematological Malignancies
The goal of this prospective observational study is to is to prospectively study the epidemiology of bloodstream infection (BSI) in patients with hematological malignancies (HM) and hematopoietic stem cell transplant (HSCT)…
- Conditions
- Hematological Malignancy, Hematopoetic Stem Cell Transplantation, Bloodstream Infection
- Trial name
- MESI-HM (NCT07900542)
- Testing
- No Intervention: Observational Cohort
- Where
- 9 sites in Jordan, Oman and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Hamad Medical Corporation
Severe Sepsis
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
Subjects previously enrolled / randomized in the ReActIF-ICE (Recovery from acute immune failure in septic shock by immune cell extracorporeal terapy - immune competence enhancement) study received either standard sepsis…
- Trial name
- ReActIF- LTO (NCT06143137)
- Where
- 2 sites in Germany
- Volunteers
- 142 people
- Sponsor
- Artcline GmbH
Severe Sepsis, Severe Sepsis Without Septic Shock
Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
This protocol will collect real-world data retrospectively from the electronic health record (EHR) as data obtained from the delivery of routine medical care to develop a machine learning (ML)-based Clinical Decision Support…
- Trial name
- NCT05304728
- Where
- 10 sites in United States
- Volunteers
- 40,000 people
- Sponsor
- Beckman Coulter, Inc.
Sepsis
Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis
The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the…
- Trial name
- IRHIS (NCT07595848)
- Testing
- CPC12S Telemonitoring System with Temperature/Humidity Sensor, IDRO Sweat Lactate Sensor
- Volunteers
- 360 people
- Sponsor
- Check Point R & D Ltd
Candidemia, Candidiasis, Invasive
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection…
- Trial name
- NCT05421858
- Testing
- Fosmanogepix, Caspofungin, Fluconazole
- Where
- 146 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Basilea Pharmaceutica
Septic Shock
First in Human Trial to Assess the Feasibility and Preliminary Safety of Adjunctive Treatment with the HemoSystem REBOOT in Critically Ill Patients with Sepsis-induced Immunosuppression
The aim of this randomized controlled trial is to restore immune function by selectively removing three mediators largely contributing to sepsis-induced immunosuppression from extracorporeal circulation.
- Trial name
- RESTORE I (NCT06258291)
- Testing
- Hemosystem REBOOT
- Where
- 2 sites in Switzerland
- Volunteers
- 16 people
- Sponsor
- hemotune AG
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Sepsis
Quality of Life in Patients With Post-Sepsis Syndrome
The aim of the study is to assess health status and quality of life during the post-sepsis period using patient-reported outcome measures.
- Trial name
- NCT07889804
- Testing
- Efferon LPS
- Where
- 5 sites in Russia
- Volunteers
- 300 people
- Sponsor
- Efferon JSC
Sepsis
NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
This Phase 2a study will evaluate the safety and efficacy of nogapendekin alfa inbakicept (NAI) plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia.
- Trial name
- NCT07783789
- Testing
- Nogapendekin alfa inbakicept (NAI)
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
Relapsed/Refractory Multiple Myeloma (RRMM)
Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who…
- Trial name
- POPLIN (NCT07609940)
- Testing
- Linvoseltamab, Tocilizumab
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Regeneron Pharmaceuticals