A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
1 other identifier
observational
2,000
2 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2020
CompletedFirst Submitted
Initial submission to the registry
October 28, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 30, 2024
October 1, 2024
5.1 years
October 28, 2024
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary objective
To derive and verify the diagnostic performance of a host-response tool based on novel biomarkers for predicting disease severity in adult patients, aged 18 years or older, presenting with clinical suspicion of acute infection/sepsis.
3,14 and 28 Days
Study Arms (2)
Suspected infection/sepsis
Patient presenting with a clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation.
Healthy Individuals
No clinical suspicion of acute infection.
Eligibility Criteria
patients presenting with suspected infection/sepsis as defined by the attending physician, based on clinical presentation and laboratory/radiological findings. Additionally, the study will recruit healthy individuals across all study sites.
You may not qualify if:
- Suspected acute infection/sepsis patients
- HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
- Pregnancy- self reported or medically confirmed. Healthy individuals
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Maimonides MC
New York, New York, 11219, United States
MCW
Milwaukee, Wisconsin, 53226, United States
Carmel MC
Haifa, 3436212, Israel
Rambam MC
Haifa, 3902908, Israel
Edith Wolfson MC
Holon, 2240832, Israel
Shaare Zedek MC
Jerusalem, 93722, Israel
Beilinson MC
Petah Tikva, 4649275, Israel
Sheba Tel-HaShomer MC
Tel Aviv, 52621, Israel
Related Links
Biospecimen
Plasma , Serum , whole Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2024
First Posted
October 30, 2024
Study Start
November 12, 2020
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share