A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-resp… (NCT06665542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
United States, Israel2,000 participantsStarted 2020-11-12
Plain-language summary
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals.
Study main objective is to derive and verify a host response based score to predicte severe outcome.
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.
Suspected acute infection/sepsis patients
Patients eligible for inclusion are required to fulfill all of the following criteria:
* Written informed consent must be obtained from the patient or his/her legal guardian.
* Over 18 years of age
* Clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation.
Healthy individuals
Patients eligible for inclusion are required to fulfill all of the following criteria:
* Written informed consent must be obtained from the patient
* Over 18 years of age
* No clinical suspicion of acute infection.
Exclusion Criteria:
Suspected acute infection/sepsis patients
Patients fulfilling the following criteria are not eligible for inclusion in this study:
* HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
* Pregnancy- self reported or medically confirmed. Healthy individuals
Patients fulfilling the following criteria are not eligible for inclusion in this study:
* Episode of infection in the last 2 weeks
* Major trauma and\\or burns and\\or surgery in the last 2 weeks
* HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records)
* Elective surgery patients
* Pregnancy- self reported or medically confirmed
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.