The effect of aspirin on the attenuated immune system following human endotoxemia.

Phase 1

• Conditions: We will investigate the effects of acetylsalicylic acid on immunoparalysis following human endotoxemia in healthy male volunteers; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-001971-61-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Written informed consent
- Age =18 and =35 yrs
- Male
- Healthy (as confirmed by medical history, examination, ECG, blood sampling)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any medication
•Use of ASA within 6 weeks prior to the first endotoxemia day
•Smoking
•Known anaphylaxis or hypersensitivity to acetylsalicylic acid or non-investigational products
•History or signs of atopic syndrome (asthma, rhinitis with medication and/or eczema)
•History of hematological disease
•Thrombocytopenia (<150*10^9/ml) or anemia (hemoglobin < 8.0 mmol/L)
•History of intracranial hemorrhage
•Quantitative bleeding assessment tool (BAT) score>3
•History, signs or symptoms of cardiovascular disease, in particular:
•Previous spontaneous vagal collapse
•History of atrial or ventricular arrhythmia
•Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complete left bundle branch block
•Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
•Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
•Renal impairment (defined as plasma creatinine >120 µmol/l)
•Liver enzyme abnormalities (above 2x the upper limit of normal)
•Medical history of any disease associated with immune deficiency
•CRP > 20 mg/L, WBC > 12x109/L or < 4 x109/L, hemoglobin < 8 mmol/L or clinically significant acute illness, including infections, within 4 weeks before the first endotoxemia day
•Previous (participation in a study with) LPS administration
•Participation in a drug trial or donation of blood 3 months prior to first endotoxemia day
•Any vaccination within 3 months prior to the first endotoxemia day until the end of the study
•Recent hospital admission or surgery with general anesthesia (<3 months to endotoxemia day)
•Use of recreational drugs within 21 days prior to the first endotoxemia day
•Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified