Determining the Fingerprint of Endotoxin Tolerance (NCT06801873) | Clinical Trial Compass
CompletedNot Applicable
Determining the Fingerprint of Endotoxin Tolerance
Netherlands110 participantsStarted 2019-05-27
Plain-language summary
An explorative, prospective study in 100 healthy volunteers who will be challenged with endotoxin twice to identify SNPs and transcripts that are associated with the degree of endotoxin tolerance
Who can participate
Age range18 Years ā 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent
* Age ā„18 and ā¤35 yrs
* Male
* Healthy (as confirmed by medical history, examination, ECG, blood sampling)
Exclusion Criteria:
* Use of any medication
* Smoking
* History or signs of atopic syndrome (asthma, rhinitis with medication and/or eczema)
* Known anaphylaxis or hypersensitivity to the non-investigational products or their excipients.
* History or signs of hematological disease (bone marrow dysfunction):
* Thrombocytopenia (\<150\*10\^9/ml) or anemia (hemoglobin \< 8.0 mmol/L)
* Abnormalities in leukocyte differential counts
* 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, or clinically significant acute illness, including infections, within 3 weeks before labeling day
* Previous (participation in a study with) LPS administration
* Any vaccination within 3 months prior to labeling day
* Participation in a dā¦
What they're measuring
1
SNPs
Timeframe: 1 hour before the first LPS administration
2
Monocyte transcriptomes
Timeframe: 1 hour before and 4 hours after the first LPS administration
3
Endotoxin tolerance
Timeframe: From 1 hour before the first LPS challenge until 6 hours after the second LPS challenge