Molecular Biomarkers for Sepsis (NCT04280354) | Clinical Trial Compass
TerminatedNot Applicable
Molecular Biomarkers for Sepsis
Stopped: Recruitment failure
Switzerland3 participantsStarted 2022-02-16
Plain-language summary
This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Admission to the ICU of one of the participating centers.
* Cases: severe community acquired pneumonia with requirement for ICU admission.
* Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever \>38°C, CRP \>100mg/L, no infection focus expected in ≥ 24h.
* All required sample types can most likely be collected within the first 24h visits.
* Expected ICU stay of more than 24h.
Exclusion Criteria:
* Admission to the hospital within the prior 14 days.
* Patients with psychosis
* Evidence of a hospital acquired pneumonia.
* One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema.
* Patients with an acute respiratory distress Syndrome (ARDS).
* Patient which can be managed as outpatients and do not require an ICU.
* Patient where a transmission to another institution is likely within the next 24h.
* Documented rejection of the general consent or participation to research in general.
* Patients with a palliative situation and a life expectancy due to other diseases (e.g. progressed cancer) less than 28 days.
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
Detection of sepsis
Timeframe: within 7 days after study inclusion
2
Sepsis related mortality
Timeframe: within 7 days after study inclusion
3
Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)