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

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

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

Study Overview

• Status: Terminated
• Conditions: Sepsis; SIRS
• Intervention / Treatment: Other: SeptiCyte Lab molecular diagnostic test (non-interventional)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older, previously admitted to medical and/or surgical general hospital wards, who are suspected of sepsis as identified by an in-hospital early-warning screening tool.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Immunexpress
• Collaborators: Rhode Island Hospital
• Investigators: Principal Investigator: Steven Opal, MD, Memorial Hospital of Rhode Island

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: SeptiCyte
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Infections
• Other Study ID Numbers: IXP 04-01b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No