Clinical trials: Infection and Inflammatory Reaction
COVID-19
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Sepsis, Adult Disease
Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital
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, Severe Sepsis, Emergency Department
- Trial name
- NCT04819035
- Testing
- CBC-DIFF Monocyte Volume Width Distribution (MDW)
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Beckman Coulter, Inc.
Acute Respiratory Distress Syndrome, Acute Lung Injury
Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis
The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in improved clearance of cytokines when…
- Conditions
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Sepsis
- Trial name
- NCT00559130
- Testing
- CytoSorb Hemoperfusion
- Where
- 6 sites in Germany
- Volunteers
- 100 people
- Sponsor
- MedaSorb Technologies, Inc
Blood Clots, Infection and Inflammatory Reaction
Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices
This study is a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions.
- Conditions
- Blood Clots, Infection and Inflammatory Reaction, Heart Disease, Kidney Disease
- Trial name
- EVOLVE (NCT07378514)
- Testing
- Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
- Volunteers
- 30,000 people
- Sponsor
- LumiraDx UK Limited
Shock, Septic
Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.
- Trial name
- ASTONISH (NCT04055909)
- Testing
- nangibotide low dose, nangibotide high dose
- Where
- 43 sites in Belgium, Denmark and 4 more
- Volunteers
- 355 people
- Sponsor
- Inotrem
Bacteremia
Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
- Trial name
- NCT01640886
- Where
- 3 sites in United States
- Volunteers
- 764 people
- Sponsor
- MicroPhage, Inc.
Septic Shock
Blood Purification for the Treatment of Pathogen Associated Shock
This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated…
- Trial name
- PURIFY-RCT (NCT05011656)
- Testing
- Seraph-100 + State of the Art Care, State of the Art Care
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- ExThera Medical Corporation
Sepsis, SIRS
The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from…
- Trial name
- NCT02704871
- Testing
- SeptiCyte Lab molecular diagnostic test (non-interventional)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Immunexpress
Nasal Congestion and Inflammations, Rhinitis
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation upper airway, characterized by nasal…
- Trial name
- NCT01393561
- Testing
- Group 1, Group 2
- Volunteers
- 167 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Sepsis, Acute Lung Injury
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS.
- Conditions
- Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome
- Trial name
- NCT01438853
- Testing
- TNX-832
- Where
- 7 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Altor BioScience
Sepsis
Clinical Trial to Evaluate MDW for Early Detection of Sepsis
This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill…
- Trial name
- NCT06267742
- Testing
- Complete Blood Count (CBC) with Differential
- Where
- 3 sites in China
- Volunteers
- 2,200 people
- Sponsor
- Beckman Coulter, Inc.
Fungemia, Fungal Infections
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem…
- Trial name
- NCT00794703
- Testing
- micafungin (Mycamine), itraconazole
- Where
- 10 sites in China
- Volunteers
- 288 people
- Sponsor
- Astellas Pharma Inc
Hypotension
Efficacy Study of a Facemask Device to Treat Hypotension
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia.
- Trial name
- NCT00256724
- Testing
- Impedance Threshold Device
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Advanced Circulatory Systems
Skin Diseases, Infectious
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
- Trial name
- CSSI (NCT00865280)
- Testing
- PTK 0796, linezolid, moxifloxacin
- Where
- 7 sites in United States
- Volunteers
- 143 people
- Sponsor
- Paratek Pharmaceuticals Inc
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 Kidney Injury Due to Sepsis
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)
The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting…
- Trial name
- CLEAR-AKI (NCT05996835)
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 79 sites in United States, Argentina and 15 more
- Volunteers
- 316 people
- Sponsor
- Novartis Pharmaceuticals
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.
Cytokine Release Syndrome in COVID-19-induced Pneumonia
Canakinumab MAP in COVID-19 Pneumonia With CRS
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia
- Trial name
- NCT04476706
- Testing
- canakinumab
- Sponsor
- Novartis Pharmaceuticals
Shock, Septic
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock
This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients…
- Trial name
- NCT03158948
- Testing
- Nangibotide 0.3 mg/kg, Nangibotide 1 mg/kg, Nangibotide 3 mg/kg
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Inotrem
Nasal Congestion and Inflammations, Rhinitis
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion…
- Trial name
- NCT01393548
- Testing
- brompheniramine + phenylephrine, Brompheniramine + pseudoephedrine
- Where
- Brazil
- Volunteers
- 879 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.