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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02704871
Other study ID # IXP 04-01b
Secondary ID
Status Terminated
Phase N/A
First received March 2, 2016
Last updated February 27, 2018
Start date June 2015
Est. completion date February 2018

Study information

Verified date February 2018
Source Immunexpress
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS


Description:

This study is evaluating a molecular diagnostic device developed to distinguish between sepsis and infection-negative SIRS among critically ill patients.

This study is a prospective, non-randomized, non-interventional, observational trial of patients with suspected sepsis in the medical and/or surgical wards. The study is being conducted on two preselected patient care units.

All patients identified by a local screening tool undergo physician review. If the suspicion of sepsis is found to be plausible, routine and conventional diagnostic procedures, including: routine bloods, blood culture and specialized tests are conducted.

Blood collection for SeptiCyte® Lab and SeptID® is drawn within 6 hours of a positive screen - both use peripheral blood as the clinical sample. The diagnostic performance of the two experimental assays will be compared to Retrospective Physician Diagnosis (RPD), and conventional microbiological culture. The results of SeptiCyte® Lab and SeptID® are not used in any clinical decision-making.

This data will be used to analyze the performance of SeptiCyte® Lab according to the endpoint measures.


Recruitment information / eligibility

Status Terminated
Enrollment 66
Est. completion date February 2018
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

1. 18-89 years old on the day of enrollment.

2. Currently admitted to study designated medical or surgical ward

3. Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.

4. Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.

5. Completed SBAR handover (Situation, Background, Assessment, Recommendation)

6. SIRS present as defined by the presence of two or more of the following:

- Temperature > 38°C or < 36°C

- Heart Rate > 90 beat/min

- Tachypnea > 20/min or PaCO2 < 32 mmHg

- WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands)

Exclusion Criteria:

1. Consent not provided

2. Patients less than 18 years of age, or 90 years of age or older.

3. Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.

4. Patients that are not located in the designated medical or surgical ward associated with the study.

5. Patients listed for "Comfort Measures Only".

6. Less than 2 SIRS criteria

7. Commencement of narrow spectrum directed antibiotics prior to screening.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SeptiCyte Lab molecular diagnostic test (non-interventional)
This is not an interventional study. Rather it involves evaluation of a molecular diagnostic test to distinguish between sepsis and infection-negative SIRS based on host response.

Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Immunexpress Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other SeptiCyte® Lab test result versus a generalized sepsis screening protocol for identifying potential cases of sepsis To compare true positive rates of sepsis diagnosis in patients identified only by the RISE2 screening protocol vs. RISE2 screening protocol plus SeptiCyte® Lab results on Day 1. 1 day
Other SeptID® test result versus microbiological reference methods for identifying pathogen(s) To assess the performance of the SeptID® test against microbiological reference methods for identifying the a pathogen via blood culture. 7 days
Primary SeptiCyte® Lab test result versus Retrospective Physician Diagnosis (RPD) result To validate the ability of the SeptiCyte® Lab test to correctly discriminate infection positive from infection negative SIRS in hospital ward patients with two or more SIRS criteria compared to the non-reference method of retrospective physician diagnosis (RPD). 7 days
Secondary SeptiCyte® Lab test result versus test results for other sepsis biomarkes, including leukocytosis, bandemia, & procalcitonin To compare SeptiCyte® Lab test scores with other clinical sepsis biomarkers to assess its ability to discriminate infection positive from infection negative SIRS. 7 days
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