The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02704871
• Other study ID #: IXP 04-01b
• 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
• 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.

Related Conditions & MeSH terms

• Infection
• Sepsis
• SIRS

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

External Links

•   Sponsor's website