Clinical trials: Sepsis
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Sepsis
Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
The goal of this clinical trial is to learn if YD0743 works to treat sepsis-associated acute respiratory distress syndrome (ARDS) in adult patients admitted to the Intensive Care Unit.
- Trial name
- NCT07413094
- Testing
- YD0743
- Where
- China
- Volunteers
- 309 people
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
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-associated Acute Kidney Injury
Concept Elicitation and Patient Experience Mapping in SA-AKI
This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI)
- Trial name
- NCT07180238
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis 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
Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form.
- Trial name
- NCT06426121
- Testing
- test Aerobic/F Culture Vials, control Aerobic/F Culture Vials
- Where
- China
- Volunteers
- 394 people
- Sponsor
- Becton, Dickinson and Company
Fever, Sepsis
AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring
The purpose of this research study is to evaluate the effectiveness of the AION BIOSYTEMS, INC. tempshield ("Shield") temperature monitoring device and platform in detecting body temperature for children 2-4 years old.
- Trial name
- NCT07145541
- Testing
- Aion Tempshield Device
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- AION Biosystems
Adult Patients at High Risk of Sepsis
Serial Measurement of Pancreatic Stone Protein (PSP) for Sepsis Early Detection in ICU Patients
In this study, 250 patients with high-risk of sepsis will be enrolled, including ≥ 50 subjects with confirmed sepsis. Diagnostic criteria for sepsis should meet the Third International Consensus Definitions for Sepsis and Septic…
- Trial name
- NCT07232784
- Testing
- blood sampling
- Where
- 3 sites in China
- Volunteers
- 250 people
- Sponsor
- Fapon Biotech Inc.
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, Community-acquired Pneumonia
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
- Conditions
- Sepsis, Community-acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute
- Trial name
- NCT04612413
- Testing
- Allocetra-OTS
- Where
- 31 sites in Belgium, France and 3 more
- Volunteers
- 148 people
- Sponsor
- Enlivex Therapeutics Ltd.
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.
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.
Sepsis, Septicemia
A Rapid Diagnostic of Risk in Hospitalized Patients Using Machine Learning
In this study, the investigators will deploy a software-based clinical decision support tool (eCARTv5) into the electronic health record (EHR) workflow of multiple hospital wards.
- Conditions
- Sepsis, Septicemia, Respiratory Failure, Hemodynamic Instability
- Trial name
- NCT05893420
- Testing
- eCARTv5 clinical deterioration monitoring, Standard of care control
- Where
- 3 sites in United States
- Volunteers
- 30,000 people
- Sponsor
- AgileMD, Inc.
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
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, 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
Sepsis, Infection
Initial Feasibility Study of the CycloPE® Device
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of the PATH EX CycloPE® device on suspected bacteremia-associated sepsis.
- Conditions
- Sepsis, Infection, Bacteremia Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
- Trial name
- NCT06970899
- Testing
- PATH EX CycloPE® Device
- Where
- Armenia
- Volunteers
- 15 people
- Sponsor
- PATH EX, Inc.