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Effect of different drugs on the immune response during inflammation: the DEDICATE-LPS study
EU CTIS ID: 2023-506556-24-00
What this study is testing
1. To determine the immunomodulatory effects of dexamethasone, tocilizumab and anakinra in healthy volunteers undergoing repeated experimental human endotoxemia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs
- 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
- Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
- 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
See the full eligibility 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.
- Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs
- 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
- Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
- 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
- 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 of psychiatric disorders
- History or signs of haematological disease
- History or signs of thromboembolic disorders
- History of peptic / gastric ulcer disease
- 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 < 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.