Clinical trials: Infection and Inflammatory Reaction
Skin Infection
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Primary Objective: To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.
- Trial name
- CG400549 (NCT01593761)
- Testing
- CG400549
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CrystalGenomics, Inc.
Uveitis, Anterior, Panuveitis
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis
- Trial name
- LUMINATE (NCT00404885)
- Testing
- LX211
- Where
- 30 sites in United States, Austria and 5 more
- Volunteers
- 108 people
- Sponsor
- Lux Biosciences, Inc.
Candidemia, Mycoses
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
- Conditions
- Candidemia, Mycoses, Fungal Infection, Fungemia
- Trial name
- ReSPECT (NCT04368559)
- Testing
- Rezafungin for Injection, Posaconazole, Fluconazole
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 602 people
- Sponsor
- Mundipharma Research Limited
Skin Infections (Acne)
Bioequivalence Study for an Isotretinoin
The objective of this study was to confirm if two formulations of isotretionin (capsules) are bioequivalent. Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product Roaccutan® 20 mg (Productos…
- Trial name
- NCT01863615
- Testing
- Isotretinoin 40 mg
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
VENUS: Septic Gene Expression Using SeptiCyte
The investigators seek to evaluate a new test for determining presence of infection/sepsis as compared to non-infection/systemic inflammatory response syndrome among critically ill patients within the first 24 hours of their…
- Trial name
- VENUS (NCT02127502)
- Where
- 6 sites in United States
- Volunteers
- 379 people
- Sponsor
- Immunexpress
Bacteremia
Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform, two…
- Trial name
- NCT01184339
- Testing
- MicroPhage S. aureus/MSSA/MRSA Blood Culture Test
- Volunteers
- 1,165 people
- Sponsor
- MicroPhage, Inc.
Respiratory Tract Infections, Urinary Tract Infections
HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study
This study will analyze gene expression data (HostDx Sepsis test) from blood samples collected from participants with suspected infections.
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Skin and Soft Tissue Infections, Intraabdominal Infections
- Trial name
- NCT03744741
- Testing
- HostDx Sepsis
- Where
- 7 sites in United States, Greece
- Volunteers
- 585 people
- Sponsor
- Inflammatix
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, Fungemia
Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture
The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST…
- Trial name
- NCT02719769
- Where
- 14 sites in United States
- Volunteers
- 4,009 people
- Sponsor
- Accelerate Diagnostics, Inc.
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and…
- Conditions
- Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma
- Trial name
- NCT00285259
- Testing
- VCL-CB01, Phosphate-buffered Saline (PBS)
- Where
- 22 sites in United States
- Volunteers
- 112 people
- Sponsor
- Astellas Pharma Inc
Sepsis, Abdominal Sepsis
Personalised Real-time Interoperable Sepsis Monitoring (PRISM)
The goal of this prospective observational study is to develop and utilize an Artificial Intelligence (AI) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery.
- Conditions
- Sepsis, Abdominal Sepsis, Infections, Clinical Deterioration
- Trial name
- PRISM (NCT06238180)
- Testing
- PRISM Tool
- Where
- Greece
- Sponsor
- Aisthesis Medical P.C.
Skin and Subcutaneous Tissue Bacterial Infections
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).
- Trial name
- NCT01811732
- Testing
- Delafloxacin, Vancomycin, Aztreonam
- Where
- 50 sites in United States, Croatia and 5 more
- Volunteers
- 660 people
- Sponsor
- Melinta Therapeutics, Inc.
B-cell Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia
Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies
The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).
- Trial name
- NCT02924402
- Testing
- XmAb13676
- Where
- 23 sites in United States, France and 2 more
- Volunteers
- 154 people
- Sponsor
- Xencor, Inc.
Respiratory Failure, Respiratory Arrest
Postoperative Respiratory Abnormalities
The study aims to determine how historical cases of respiratory abnormalities are documented by clinicians in the electronic health records (EHR) of Memorial Hermann Healthcare System (MHHS) inpatient facilities.
- Conditions
- Respiratory Failure, Respiratory Arrest, Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- AI-ARF (NCT04079829)
- Testing
- Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Efficacy Care R&D Ltd
Periodontal Diseases, Gingivitis
Randomized Trial of a Gum Health Formulation
The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device)…
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis, Halitosis
- Trial name
- NCT03196648
- Testing
- Gingival health formulation in an accelerating device, Gingival health formulation on a toothbrush, OTC fluoride toothpaste
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Glo Science, Inc.
Severe Sepsis, Septic Shock
A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock
The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with…
- Trial name
- NCT01145560
- Testing
- AZD9773
- Where
- 52 sites in Australia, Belgium and 5 more
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
Septic Shock
Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148
Septic shock is a potentially life-threatening condition that can result in multi-organ dysfunction syndrome (MODS) and mortality.
- Trial name
- SSAIL (NCT02317549)
- Testing
- LB1148
- Where
- 34 sites in United States, Canada
- Volunteers
- 8 people
- Sponsor
- Leading BioSciences, Inc
Sepsis
NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
This Phase 2a study will evaluate the safety and efficacy of nogapendekin alfa inbakicept (NAI) plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia.
- Trial name
- NCT07783789
- Testing
- Nogapendekin alfa inbakicept (NAI)
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
Acute Bacterial Skin and Skin Structure Infections
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
- Trial name
- NCT02570490
- Testing
- sodium fusidate, linezolid
- Where
- 62 sites in United States, Puerto Rico
- Volunteers
- 716 people
- Sponsor
- Arrevus Inc.