Clinical trials: Clinical Sepsis
Nosocomial Infections, Sepsis
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing…
- Conditions
- Nosocomial Infections, Sepsis, Staphylococcal Infections, Candidemia
- Trial name
- NCT00113191
- Testing
- Veronate
- Where
- 93 sites in United States, Canada
- Volunteers
- 2,000 people
- Sponsor
- Bristol-Myers Squibb
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.
Severe Sepsis
Effect of a Sepsis Prediction Algorithm on Clinical Outcomes
In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.
- Trial name
- NCT03960203
- Testing
- InSight
- Volunteers
- 75,147 people, healthy volunteers welcome
- Sponsor
- Dascena
Escherichia Coli Bacteremia, Klebsiella Bacteraemia
Switch to Oral Antibiotics in Gram-negative Bacteremia
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have…
- Conditions
- Escherichia Coli Bacteremia, Klebsiella Bacteraemia, Enterobacter Bacteraemia, Serratia Bacteraemia
- Trial name
- SOAB (NCT04146922)
- Testing
- Step down to oral antimicrobial therapy, IV antimicrobial therapy
- Where
- 7 sites in Bahrain, Kuwait and 2 more
- Volunteers
- 176 people
- Sponsor
- Hamad Medical Corporation
Sepsis
A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms
This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device.
- Trial name
- NCT04606862
- Testing
- Morley Medical Sepsis Software Device
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Morley Medical
Sepsis
A Study of HY209 in Healthy Male Volunteers for Sepsis
A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers
- Trial name
- NCT04255979
- Testing
- HY209
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shaperon
Sepsis, Sepsis Associated DIC
A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis
This is an exploratory study in which data from people with sepsis (a serious condition in which the body responds to an infection that damages vital organs) admitted to an Intensive care unit (ICU) who will receive treatment are…
- Trial name
- NCT06986798
- Testing
- Local standard medical care
- Where
- 31 sites in Austria, Belgium and 5 more
- Volunteers
- 150 people
- Sponsor
- Bayer
Bacterial Infections, Bone Diseases, Infectious
Fosfomycin I.v. for Treatment of Severely Infected Patients
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin…
- Conditions
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections
- Trial name
- FORTRESS (NCT02979951)
- Where
- 50 sites in Austria, Germany and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Infectopharm Arzneimittel GmbH
Sepsis, Septic Shock
Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis
The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including…
- Conditions
- Sepsis, Septic Shock, Sepsis With Acute Organ Dysfunction
- Trial name
- NCT03113721
- Where
- 5 sites in United States
- Volunteers
- 571 people
- Sponsor
- Axis Shield Diagnostics Ltd
Sepsis, Adult Disease
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in…
- Conditions
- Sepsis, Adult Disease, Emergency Department, Severe Sepsis
- Trial name
- NCT04804306
- Testing
- Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
- Where
- United States
- Volunteers
- 198 people
- Sponsor
- Beckman Coulter, Inc.
Toxic Shock Syndrome, Vaccination; Sepsis
rTSST-1 Variant Vaccine Phase 1 First-in-man Trail
Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen toxins are the main causative agents.
- Trial name
- rTSST-1 (NCT02340338)
- Testing
- rTSST-1 Variant Candidate Vaccine
- Where
- Austria
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Biomedizinische Forschungs gmbH
Bacteremia
Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates
This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and…
- Trial name
- NCT04295915
- Testing
- Specimens that meet inclusion criteria
- Where
- 3 sites in United States
- Volunteers
- 731 people, healthy volunteers welcome
- Sponsor
- Accelerate Diagnostics, Inc.
Septic Shock
ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital…
- Trial name
- ASSET (NCT02335723)
- Testing
- Alteco LPS Adsorber
- Where
- 6 sites in Finland, Norway and 1 more
- Volunteers
- 15 people
- Sponsor
- Alteco Medical AB
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Systemic Inflammatory Response Syndrome (SIRS), Sepsis
IMproved PREdiction of Severe Sepsis in the Emergency Department
The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock
- Trial name
- IMPRESSED (NCT01392508)
- Where
- 5 sites in United States, Sweden
- Volunteers
- 759 people
- Sponsor
- Axis Shield Diagnostics Ltd
Sepsis
Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.
The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on…
- Trial name
- NCT03474809
- Testing
- Blood sampling
- Where
- 14 sites in France, Italy and 2 more
- Volunteers
- 296 people
- Sponsor
- Abionic SA
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, 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.
Catheter-related Bloodstream Infection
Expanded Access Program for Patients at Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials
The EAP for DefenCath is designed to provide access to a broader population of adult and pediatric patients using catheters for various serious medical conditions.
- Trial name
- NCT06707480
- Testing
- Taurolidine and Heparin
- Sponsor
- CorMedix Therapeutics
Bacteremia, Soft Tissue Infections
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection…
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Trial name
- NCT03643952
- Testing
- Daptomycin for Injection
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC