Clinical trials: SIRS(Systemic Inflammatory Response Syndrome)
- Condition SIRS(Systemic Inflammatory Response Syndrome)
- Funder type Industry (pharma, biotech, devices)
Sepsis
Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
- Trial name
- NCT04414189
- Testing
- HostDx Sepsis
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Inflammatix
Sepsis
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
This Phase IIa Randomized, Double-blind, Parallel Group, Placebo-controlled, multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Intravenous Injection of SY-005（recombinant human annexin…
- Trial name
- NCT04898322
- Testing
- SY-005
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Bacteremia
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
- Trial name
- DIREBT (NCT01919762)
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- T2 Biosystems
Endocarditis, Bacterial, Infective Endocarditis
Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of…
- Trial name
- HDSAB (NCT00695903)
- Testing
- daptomycin, vancomycin
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Candidiasis, Invasive, Candidemia
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis including candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous…
- Trial name
- MARIO (NCT05178862)
- Testing
- SCY-078, Fluconazole, Echinocandin
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 68 people
- Sponsor
- Scynexis, Inc.
Candidaemia
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia
This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.
- Trial name
- SLIC (NCT00509834)
- Testing
- hLF1-11
- Where
- Netherlands
- Sponsor
- AM-Pharma
Bacteremia
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects…
- Trial name
- NCT02208063
- Testing
- Telavancin, Vancomycin, Daptomycin
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Cumberland Pharmaceuticals
Sepsis, Anemia
StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived…
- Conditions
- Sepsis, Anemia, Bleeding, Erythrocytosis
- Trial name
- NCT05118048
- Testing
- Lactate, Hemoglobin, Hematocrit
- Where
- 3 sites in United States
- Volunteers
- 285 people
- Sponsor
- Nova Biomedical
Bacteremia
Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.
- Trial name
- NCT00505258
- Testing
- ceftobiprole medocaril
- Sponsor
- Basilea Pharmaceutica
Sepsis
Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical…
- Trial name
- NCT04529733
- Testing
- IB10 sphingotest PCT+
- Volunteers
- 300 people
- Sponsor
- Nexus DX
Sepsis, Severe Sepsis
Gram Type Infection-Specific Sepsis Identification Using Machine Learning
The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a Gram type infection-specific…
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Trial name
- NCT03734484
- Testing
- InSight
- Volunteers
- healthy volunteers welcome
- Sponsor
- Dascena
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.
Sepsis
Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 （Recombinant Human Annexin A5）in Healthy Subjects
This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.
- Trial name
- NCT04217629
- Testing
- SY-005
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Sepsis, Venous Thromboembolism
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
This is an observational study in which data already collected from people with venous thromboembolism (VTE) due to sepsis (blood poisoning) are studied.
- Conditions
- Sepsis, Venous Thromboembolism, Disseminated Intravascular Coagulation
- Trial name
- NCT06765681
- Testing
- Diagnosis of both VTE and sepsis
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Bayer
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, Shock, Septic
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis
Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent…
- Conditions
- Sepsis, Shock, Septic, Sepsis Syndrome, Septicemia
- Trial name
- NCT00046072
- Testing
- E5564
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- Eisai Inc.
Bacteriaemia, Catheter Related Bloodstream Infection
Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)
The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality.
- Trial name
- NCT00555282
- Testing
- central venous catheter
- Where
- 2 sites in Czechia
- Volunteers
- 680 people
- Sponsor
- B. Braun Melsungen AG
Coronavirus, COVID
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and…
- Conditions
- Coronavirus, COVID, ARDS, Cytokine Storm
- Trial name
- NCT04415073
- Testing
- SNDX-6352
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Syndax Pharmaceuticals
Respiratory Distress Syndrome, Adult
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients.
- Trial name
- NCT03202394
- Testing
- BIO-11006
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- BioMarck Pharmaceuticals, Ltd.
Catecholamine-resistant Hypotension (CRH), Distributive Shock
A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension…
- Conditions
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Septic Shock
- Trial name
- NCT03623529
- Testing
- LJPC-501 (angiotensin II)
- Where
- 2 sites in Belgium, Lithuania
- Volunteers
- 100 people
- Sponsor
- La Jolla Pharmaceutical Company