A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06665542

Enrollment

2000

Registered

2024-10-30

Start date

2020-11-12

Completion date

2025-12-31

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Infection, Sepsis

Keywords

Host response, Suspected sepsis, Suspected acute infection, Biomarkers, ARDS, Septic shock, Sepsis associated AKI

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.

Detailed description

For determining disease severity each enrolled patient will be assigned as either severe outcome patient or non severe outcome patient according to predefined criteria. (or healthy). Participation in the study requires the collection of routine patient data and blood sample. Blood samples will be used for measurements of host biomarkers that predict disease severity. The blood samples will be collected upon enrollment. In addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission. Enrolled patients will be managed according to the current standard of care per standard institutional procedures. Results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Primary objective	3,14 and 28 Days	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.

Countries

Israel, United States

Outcome results