Clinical trials: Bloodstream Infections
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections.
- Conditions
- Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection, Meningitis, Bacterial
- Trial name
- RIV- CARE (NCT07431307)
- Testing
- BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT)
- Volunteers
- 120 people
- Sponsor
- BioVersys AG
Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS)
Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis…
- Conditions
- Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), Sepsis, Lymphopenia
- Trial name
- NCT07492875
- Testing
- Nogapendekin alfa inbakicept (NAI), agenT-797
- Sponsor
- ImmunityBio, Inc.
Severe Sepsis, Septic Shock
Adrenomedullin and Outcome in Severe Sepsis and Septic Shock
The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings…
- Trial name
- AdrenOSS (NCT02393781)
- Where
- 24 sites in Belgium, France and 3 more
- Volunteers
- 596 people
- Sponsor
- Sphingotec GmbH
Acute Kidney Injury, Peritonitis
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Trial name
- NCT03403751
- Testing
- Reltecimod 0.5 mg/kg
- Where
- 56 sites in United States, France
- Volunteers
- 58 people
- Sponsor
- Atox Bio Ltd
Severe Sepsis
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
Subjects previously enrolled / randomized in the ReActIF-ICE (Recovery from acute immune failure in septic shock by immune cell extracorporeal terapy - immune competence enhancement) study received either standard sepsis…
- Trial name
- ReActIF- LTO (NCT06143137)
- Where
- 2 sites in Germany
- Volunteers
- 142 people
- Sponsor
- Artcline GmbH
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.
Mantle Cell Lymphoma, COVID-19
A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole
This Phase 1 study is being conducted to support the clinical development of acalabrutinib in hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to respiratory failure, eg, they may require…
- Trial name
- NCT04564040
- Testing
- Acalabrutinib Treatment A, Acalabrutinib Treatment B, Acalabrutinib Treatment C
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Sepsis
Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
The goal of this clinical trial is to learn if YD0743 works to treat sepsis-associated acute respiratory distress syndrome (ARDS) in adult patients admitted to the Intensive Care Unit.
- Trial name
- NCT07413094
- Testing
- YD0743
- Where
- China
- Volunteers
- 309 people
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Sepsis, COVID-19
SQuISH-COVID: A Pilot Study
This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious…
- Trial name
- NCT04372472
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cytovale, Inc.
Inflammation
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response. In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide [LPS]) elicits a…
- Trial name
- NoSIRS (NCT01944228)
- Testing
- Vagal Nerve Stimulation
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Severe Sepsis
S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
The purpose of this study is to determine if Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.
- Trial name
- SAFEbt (NCT01312675)
- Testing
- S.A.F.E.BT
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- B. Braun Medical Inc.
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
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.
Catheter-related Infections
Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution as…
- Trial name
- NCT02901717
- Testing
- Mino-Lok, Antibiotic lock
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 144 people
- Sponsor
- Leonard-Meron Biosciences, Inc.
Infection
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily…
- Trial name
- NCT01690559
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 704 people
- Sponsor
- Bayer
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.
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
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.
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