Actively Recruiting
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
Led by Radboud University Medical Center · Updated on 2025-04-04
52
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are: * What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model? * What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model? Researchers will compare these drugs to a placebo (a look-alike substance that contains no drug). Participants will visit the Intensive Care research department on two or five occasions (screening included): * The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord. * The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group. During an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.
CONDITIONS
Official Title
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 60;18 and 60;35 years
- Body mass index (BMI) 60;18 and 60;30 kg/m2
- Healthy as determined by medical history, physical exam, vital signs, ECG, and lab tests
- Able to understand and sign informed consent before joining the study
You will not qualify if you...
- Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs
- Known anaphylaxis or allergy to study drugs or their ingredients
- History of chronic headache or past post-dural puncture headache
- History or signs of severe atopic conditions like asthma, rhinitis needing medication, or eczema
- History of immune deficiency diseases
- Cancer diagnosis within the last 5 years (except localized skin cancer or carcinoma in situ)
- History or signs of blood disorders
- History or signs of blood clotting disorders
- History of peptic or gastric ulcers
- History of psychiatric disorders
- Low platelet count (less than 150 x 10^9/mL) or anemia (less than 8.0 mmol/L)
- History or symptoms of cardiovascular disease including vagal collapse, arrhythmias, certain ECG abnormalities, high or low blood pressure
- Kidney impairment with plasma creatinine above 120 bcmol/L
- Liver enzyme levels above twice the normal limit
- Signs of infection including elevated CRP or abnormal white blood cell counts
- Acute illnesses such as infections or trauma in the month before the first LPS challenge
- Prior participation in endotoxin (LPS) administration studies
- Participation in experimental drug trials within 3 months before first LPS challenge
- Vaccination or blood donation within 1 month before first LPS challenge
- Recent hospital admission or surgery with general anesthesia within 3 months before first LPS challenge
- Use of recreational drugs within 2 weeks before first LPS challenge
- Suspected inability to follow the study protocol
- Unable to provide written informed consent or participate due to language or mental reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Actively Recruiting
Research Team
N
Nicole Waalders, MD
CONTACT
M
Matthijs Kox, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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