UMEM Research Studies

Study TitleStudy DatesSponsorStatusPrimary Investigator(s)Other Investigator(s)
A Single-Blind, Randomized Study Comparing the Efficacy and Safety of a Single Dose of TNX-1300 to Placebo with Usual Care (UC) for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Emergency Department (ED) Subjects 12/01/2023 to 12/31/2024 Tonix Pharmaceuticals, Inc. Not yet recruiting Richard Wilkerson
Description:

Background:  

Cocaine abuse and dependence and their sequelae are significant problems globally and in the United States. According to the US Centers for Disease Control and Prevention (CDC), in 2021 the number of overdose deaths involving cocaine reached 24,900 individuals. Cocaine-related emergency department (ED) visits are associated with chest pain, arrhythmias, myocardial ischemia, systolic hypertension, exacerbation of asthma, agitation, and seizures. However, there is currently no product licensed to treat cocaine intoxication.  

Based on its non-clinical efficacy profile, TNX-1300 shows promise as a novel compound for treating the cause of cocaine intoxication rather than the symptoms only. Thus, this is a single-blind, randomized study to investigate the efficacy and safety of TNX-1300 as a medical intervention to treat acute cocaine intoxication in the ED setting.  

 

Study Objectives:  

Primary: To evaluate the efficacy of TNX-1300 in the treatment of cocaine intoxication via blood pressure (BP) 60 minutes after intravenous (IV) administration in the ED setting.  

Secondary: To further evaluate the efficacy of TNX-1300 in the treatment of cocaine intoxication via assessment of BP, electrocardiograms (ECGs), and the Stimulant Intoxication Scale (SIS) at selected time points after IV administration in the ED setting.  

 


Clinicaltrials.gov ID: NCT06045793
Keywords:
cocaine, Tonix
Prospective Blood Culture Collection of Patients with Suspected Cases of Bloodstream Infection (BSI) 05/25/2023 to 12/31/2023 Becton Dickinson IDS – Integrated Diagnostic Solutions Not yet recruiting Richard Wilkerson
Description:

Study Objectives: To collect blood culture samples from participants suspected of having a BSI, based off pre-existing standing orders or new pending standard of care orders. 

 

Primary Endpoints: Not Applicable. This is a biological sample collection protocol only. 


Clinicaltrials.gov ID: NA
Keywords:
BSI- Bloodstream Infection Blood Cultures
Percutaneous Ultrasound Gastrostomy technique 08/01/2019 to 07/12/2023 CoapTech Completed Richard Wilkerson
Daniel Haase
Kami Windsor
WanTsu Wendy Chang
Description:

A single-center, non-randomized, non-blinded feasibility study to evaluate the performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) procedure that utilizes a novel device in conjunction with widely available ultrasound technology.


Clinicaltrials.gov ID: NCT03956277
Keywords:
Gastrostomy, Percutaneous Ultrasound Gastrostomy, PUG, Feeding tube
Microparticle Levels in ACE-inhibitor Induced Angioedema 04/01/2021 to - N/A Completed Richard Wilkerson
Stephen Thom
Description:

The overall goal of this study is to determine whether the levels of microparticles may be elevated in patients with angioedema that develops as a result of the use of the class of blood pressure medications, ACE inhibitors.

Keywords:
Angioedema, ACE, ACE-inhibitor, Microparticles
ARREST PNEUMONIA ARrest RESpiraTory failure due to PNEUMONIA 12/07/2022 to - Funded by: National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) ; INDE Sponsor: Joseph Levitt, MD & Emir Festic, MD Recruiting Kami Windsor
Richard Wilkerson
Description:

Background 

Pneumonia is the leading infectious cause of hospitalization and death in the United States, with associated medical costs exceeding $10 billion annually. When patients require intensive care unit (ICU) level care, mortality exceeds 30% and survivors often require prolonged hospital stays and suffer from long-term disability. The host response to pneumonia is characterized by release of inflammatory cytokines that activate vascular endothelium and recruit neutrophils to help contain local infection. However, dysregulated inflammation can perpetuate injury leading to loss of endothelial and epithelial integrity and flooding of alveoli with protein rich edema fluid, which can lead to loss of lung compliance, refractory hypoxemia, and ultimately acute respiratory failure (ARF) and acute respiratory distress syndrome (ARDS). Loss of barrier function can also contribute to dissemination of local infection leading to septic shock and multiorgan dysfunction, which can cause ARF independent of ARDS. Currently, other than antibiotics and supportive care, there are no established treatments directly targeting the underlying lung injury that occurs with severe pneumonia. However, corticosteroids have been shown to reduce inflammation and preserve alveolar barrier function, while beta-agonists increase alveolar fluid clearance and preserve vascular permeability.  

Primary Objective 

To establish the efficacy of early treatment with an inhaled corticosteroid combined with a beta-agonist vs. placebo for the prevention of ARF in hospitalized participants with pneumonia and hypoxemia. 

Secondary Objective 

To identify baseline clinical and biological characteristics impacting risk of ARF due to pneumonia and impacting variable response to treatment. 


Clinicaltrials.gov ID: NCT04193878
Keywords:
pneumonia,
A Randomized, Double-Blind, Placebo Controlled Dose Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO) 03/02/2023 to - CalciMedica, Inc. Recruiting Richard Wilkerson
Description:

Background 

Acute pancreatitis (AP) is an acute inflammatory process of the pancreas with varying involvement of local tissues and/or more remote organ systems. Due to the dynamic nature of the disease, it leads to wide-ranging outcomes that evolve rapidly in any given patient with little predictability. 

There is no prescribed order of events that the disease course follows, beyond the basic concept of an early (usually <1-2 weeks) and a late (>1-2 weeks) phase, with the former characterised by varying degrees of pancreatic and systemic inflammation, and the latter by an anergic phase that can make patients susceptible to infection. There are currently two primary aims in the initial treatment of patients with AP. The first aim is to provide supportive therapy, and to treat specific complications that may occur. The second aim is to limit the severity of pancreatic inflammation, necrosis, and systemic inflammatory response syndrome (SIRS). There is currently no approved pharmaceutical treatment for AP, regardless of the severity of the disease. Patients are generally managed with supportive care, including fluid replacement, painkillers, oxygen, feeding via a tube or into a vein, and antibiotics.  

Primary Objectives 

  • To assess the dose response and efficacy of three different dose levels of Auxora in patients with AP and accompanying SIRS; 

  • To assess the time to medically indicated discharge in patients who are responders to early tolerance of solid food intake versus non-responders. 


Clinicaltrials.gov ID: NCT04681066
Keywords:
CARPO, pancreatitis