Clinical trials: Sepsis Syndromes
Severe Infection, Sepsis
Evaluation of MDW for Early Detection of Sepsis, Clinical Validity
The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults…
- Conditions
- Severe Infection, Sepsis, Severe Sepsis
- Trial name
- NCT03588325
- Testing
- CBC-DIFF with MDW, PCT, CRP
- Where
- 2 sites in France, Spain
- Volunteers
- 947 people
- Sponsor
- Beckman Coulter, Inc.
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI).
- Trial name
- HICOSIRS (NCT01579396)
- Testing
- septeX, standard therapy
- Where
- Germany
- Sponsor
- Vantive Health LLC
Sepsis
Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's…
- Trial name
- NCT05311046
- Testing
- Pediatric sepsis screening tool (either algorithmic or manual)
- Where
- United States
- Volunteers
- 12,961 people
- Sponsor
- Computer Technology Associates, Inc.
Acute Respiratory Distress Syndrome, Coronavirus
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical…
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure
- Trial name
- VANGARD (NCT04433546)
- Testing
- Pemziviptadil (PB1046), Low Dose (10 mg) Control
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- PhaseBio Pharmaceuticals Inc.
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.
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Systemic Inflammatory Response Syndrome, Kidney Failure, Acute
High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock
This study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD leads to a significant improvement of the…
- Trial name
- HICOSS (NCT00875888)
- Testing
- continuous venovenous hemodialysis
- Where
- 4 sites in Austria, Germany
- Volunteers
- 80 people
- Sponsor
- Vantive Health LLC
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
Immunity, Vaccine Reaction
Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions.
- Conditions
- Immunity, Vaccine Reaction, Influenza, Covid19
- Trial name
- NCT04798677
- Testing
- ABBC1 Immunoessential
- Where
- Spain
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AB Biotek
Hemodialysis
HeRO Vascular Access Device Bacteremia Study
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients.
- Trial name
- NCT00889564
- Testing
- HeRO Vascular Access Device
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Merit Medical Systems, Inc.
Severe Sepsis
Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.
- Trial name
- Pro-SEPS (NCT01025180)
- Testing
- Procalcitonin level
- Where
- 9 sites in France
- Volunteers
- 62 people
- Sponsor
- Brahms France
Staphylococcal Infections, Bacteremia
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis
The purpose of this study is to establish the tolerability of treatment with human lactoferrin 1-11 peptide (hLF1-11) administered intravenously as a single dose given for 10 consecutive days, to patients with bacteremia due to…
- Trial name
- LIST (NCT00509847)
- Testing
- human lactoferrin peptide 1-11
- Where
- Netherlands
- Sponsor
- AM-Pharma
COVID-19
101-PGC-005 for the Treatment of COVID-19
This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of…
- Trial name
- NCT05656521
- Testing
- 101-PGC-005, Dexamethasone
- Where
- 5 sites in India
- Volunteers
- 62 people
- Sponsor
- 101 Therapeutics
Sepsis, Severe Sepsis
TRIAGE: TRIage of Sepsis At emerGency dEpartment
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection.
- Trial name
- TRIAGE (NCT02739152)
- Where
- 14 sites in Belgium, France
- Volunteers
- 602 people
- Sponsor
- BioMérieux
Candidemia, Invasive Candidiases
An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris
This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C.
- Conditions
- Candidemia, Invasive Candidiases, Candida Infection
- Trial name
- APEX (NCT04148287)
- Testing
- APX001
- Where
- 2 sites in South Africa
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
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
COVID-19
A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
In December 2019, a novel pneumonia caused by a previously unknown pathogen emerged in Wuhan, China. The pathogen was soon identified as a novel coronavirus (SARS-CoV-2), which is closely related to severe acute respiratory…
- Trial name
- NCT05195749
- Testing
- 101-PGC-005 ('005) + SOC
- Where
- Israel
- Volunteers
- 3 people
- Sponsor
- 101 Therapeutics
Sepsis
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
The purpose of this study is to evaluate the performance of the Karius Infectious Diseases Plasma Sequencing Assay in patients who present to the emergency room with sepsis.
- Trial name
- NCT02730468
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Karius, Inc.
Candidiasis
The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the…
- Trial name
- NCT00056368
- Testing
- Anidulafungin, Fluconazole
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Pfizer