Clinical trials: Sepsis, Septic Shock
Septic Shock, Sepsis
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
- Conditions
- Septic Shock, Sepsis, Hypovolemia
- Trial name
- VBI-S-02 (NCT06072430)
- Testing
- VBI-S
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Vivacelle Bio
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
Septic Shock, Endotoxemia
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock
- Trial name
- TIGRIS (NCT03901807)
- Testing
- Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge
- Where
- 20 sites in United States
- Volunteers
- 157 people
- Sponsor
- Spectral Diagnostics (US) Inc.
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
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic…
- Trial name
- SYMON II (NCT06654895)
- Where
- 5 sites in United States
- Volunteers
- 700 people
- Sponsor
- Bluejay Diagnostics, Inc.
Sepsis, Septic Shock
Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted…
- Trial name
- SYMON III (NCT07425587)
- Where
- 5 sites in United States
- Volunteers
- 450 people
- Sponsor
- Bluejay Diagnostics, Inc.
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, 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.
Sepsis, Acute Kidney Injury
A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI.
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock
- Trial name
- LAPIS (NCT04434209)
- Testing
- Subject management guided by NephroCheck® test, Standard of Care
- Where
- 12 sites in United States, Belgium and 2 more
- Volunteers
- 19 people
- Sponsor
- BioMérieux
Sepsis, Disseminated Intravascular Coagulation
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.
- Trial name
- NCT06373159
- Testing
- No study intervention
- Where
- Japan
- Volunteers
- 5,740 people
- Sponsor
- Bayer
Healthy Subjects
A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229
This is a Phase I, single-center, randomized, single-blind, placebo-controlled study in healthy subjects assessing the safety, tolerability and pharmacokinetic profile of three different dose levels of M6229 when administered…
- Trial name
- NCT07285603
- Testing
- M6229
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Matisse Pharmaceuticals
Sepsis, Septic Shock
Clearance of Antibacterial Agents During Hemoperfusion in Patients With Sepsis
One of the significants health problems in the world is sepsis, with the number of cases reaching 20-30 million per year, according to the WHO.
- Trial name
- NCT06602245
- Where
- 4 sites in Russia
- Volunteers
- 30 people
- Sponsor
- Efferon JSC
Sepsis, Septic Shock
Multicenter Symphony IL-6 Monitoring Sepsis ICU Study
The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the…
- Trial name
- SYMON (NCT06181604)
- Where
- 7 sites in United States
- Volunteers
- 143 people
- Sponsor
- Bluejay Diagnostics, Inc.
Sepsis, Septic Shock
Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million.
- Trial name
- LASSONEO (NCT05707494)
- Testing
- Efferon LPS NEO
- Where
- 7 sites in Russia
- Volunteers
- 78 people
- Sponsor
- Efferon JSC
Sepsis, Acute Infection
A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
- Trial name
- NCT06665542
- Where
- 8 sites in United States, Israel
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- MeMed Diagnostics Ltd.
Shock, Septic
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock
This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients…
- Trial name
- NCT03158948
- Testing
- Nangibotide 0.3 mg/kg, Nangibotide 1 mg/kg, Nangibotide 3 mg/kg
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Inotrem
Maternal sepsIs
Selective Lipopolysaccharide Hemosorption in Maternal Sepsis
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. The prevalence and frequency of obstetric sepsis are quite pronounced.
- Trial name
- MINERVA (NCT05711901)
- Testing
- Efferon LPS
- Where
- 7 sites in Russia
- Volunteers
- 30 people
- Sponsor
- Efferon JSC
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, Septic Shock
Combined Hemoperfusion and Therapeutic Plasma Exchange for Treatment of Patients With Septic Shock
Sepsis is a critical burden for a healthcare. From 2000 to 2020, the number of publications and clinical studies on the topic of Sepsis and septic shock on the National Library of Medicine resource The National Center for…
- Trial name
- NCT06404424
- Testing
- Efferon LPS, Efferon CT
- Where
- Russia
- Volunteers
- 82 people
- Sponsor
- Efferon JSC
Septic Shock
Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins.
- Trial name
- AMETHYST (NCT04961658)
- Testing
- GEM00220
- Where
- 4 sites in Canada
- Volunteers
- 11 people
- Sponsor
- Northern Therapeutics