Clinical trials: Systemic Infection
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
Systemic Lupus Erythematosus
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while…
- Trial name
- NCT07630714
- Testing
- Anifrolumab + APFS
- Where
- 39 sites in Australia, Belgium and 8 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Mycoses
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor…
- Trial name
- NCT01232504
- Testing
- rhGM-CSF group, rhG-CSF+rhGM-CSF group, rhG-CSF group
- Where
- 5 sites in China
- Volunteers
- 206 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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
Plague, Plague, Bubonic
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could…
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague
- Trial name
- SMARTPRT (NCT04688996)
- Testing
- Lateral Flow Assay for Pathogens of the Plague
- Where
- 2 sites in United States, Madagascar
- Volunteers
- 500 people
- Sponsor
- Brimrose Technology Corporation
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.
MRSA Bloodstream Infection, MRSA Bacteremia
Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI)…
- Conditions
- MRSA Bloodstream Infection, MRSA Bacteremia, MRSA Right-sided Endocarditis, Covid19
- Trial name
- NCT04597242
- Testing
- Exebacase
- Where
- 2 sites in United States
- Sponsor
- ContraFect
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
COVID-19, Infectious Disease
Continuous Temperature Telemonitoring of Patients With COVID-19 and Other Infectious Diseases in Hospital at Home Using Viture
The aim of this cohort study is to validate Viture®, a continuous temperature telemonitoring system, evaluating the level of agreement with a standard commercially available digital axillary thermometer.
- Conditions
- COVID-19, Infectious Disease, Tract Infection, Urinary, Bacteremia
- Trial name
- Viture (NCT05959928)
- Testing
- Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely
- Where
- Spain
- Volunteers
- 208 people
- Sponsor
- Vitio Medical S.L.
Sepsis
Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at…
- Trial name
- NCT04105699
- Testing
- Blood sampling
- Where
- 5 sites in United States
- Volunteers
- 544 people
- Sponsor
- Abionic SA
Catheter-Related Infections
Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Central Line Associated Bloodstream Infection.
- Trial name
- MLK (NCT04513821)
- Testing
- Mino-Lok Therapy (MLT)
- Where
- 30 sites in United States, Puerto Rico
- Sponsor
- Leonard-Meron Biosciences, Inc.
Organ Dysfunction Syndrome Sepsis
Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis.
- Trial name
- P-SOFA-1 (NCT03925857)
- Testing
- Allocetra-OTS
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Enlivex Therapeutics Ltd.
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-2 (NCT02447172)
- Testing
- Gentamicin Collagen sponge
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 524 people
- Sponsor
- Innocoll
Wound Infection, Abscess
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant…
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Trial name
- SOLO I (NCT01252719)
- Testing
- Single-Dose IV Oritavancin Diphosphate, IV Vancomycin
- Where
- United States
- Volunteers
- 968 people
- Sponsor
- Melinta Therapeutics, Inc.