BridgeMD
New treatment option for Sepsis
Official title Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
ClinicalTrials.gov ID: NCT06624436
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sepsis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, men only. Healthy volunteers may be eligible.
You may be able to join if
- Male people 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.
You likely can't join if
- 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)
See the full eligibility criteria
- Male people 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.
- 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 \> 90 mmHg)
- Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50 mmHg)
- Renal impairment (defined as plasma creatinine \>120 μmol/L)
- Liver enzyme abnormalities (above 2x the upper limit of normal)
- Signs of infection (CRP \> 20 mg/L, white blood cells \> 12x109/L or
- lt; 4x109/L)
- Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge
- Previous (participation in a study with) endotoxin (LPS) administration
- Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge
- Any vaccination or blood donation within 1 month prior to the first LPS challenge
- Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge
- Use of recreational drugs within 2 weeks prior to the first LPS challenge
- Suspected of not being able to comply with the trial protocol
- Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.