Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human End… (NCT06624436) | Clinical Trial Compass
RecruitingPhase 4
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
Netherlands52 participantsStarted 2024-10-24
Plain-language summary
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.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male subjects aged ≥18 and ≤35 years
* Body mass index (BMI) ≥18 and ≤30 kg/m2
* Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)
* Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.
Exclusion Criteria:
* Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs
* Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
* History of chronic headache or previous post-dural puncture headache (PDPH)
* History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)
* History of any disease associated with immune deficiency
* History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ)
* History or signs of haematological disease
* History or signs of thromboembolic disorders
* History of peptic / gastric ulcer disease
* History of psychiatric disorders
* Thrombocytopenia (\<150\*109/mL) or anaemia (\<8.0 mmol/L)
* History, signs or symptoms of cardiovascular disease, in particular:
* Prone to vagal collapse
* History of atrial or ventricular arrhythmia
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block
* Hypertension (defined as RR systolic \> 160 or RR diastolic \>…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-group differences in plasma TNF concentrations upon the second LPS challenge
Timeframe: 1 day (during second LPS challenge)
2
Within and between-group differences in CSF TNF concentrations during repeated experimental human endotoxemia