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

NCT02704871 | Terminated

• 1 other identifier: IXP 04-01b
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sepsis; SIRS

Keywords

SeptiCyte

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SeptiCyte® Lab test result versus test results for other sepsis biomarkes, including leukocytosis, bandemia, & procalcitonin

  7 days

Other Outcomes (2)

• SeptiCyte® Lab test result versus a generalized sepsis screening protocol for identifying potential cases of sepsis

  1 day

• SeptID® test result versus microbiological reference methods for identifying pathogen(s)

  7 days

Interventions

SeptiCyte Lab molecular diagnostic test (non-interventional) OTHER

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years old on the day of enrollment.
• Currently admitted to study designated medical or surgical ward
• Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.
• Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.
• Completed SBAR handover (Situation, Background, Assessment, Recommendation)
• 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)

You may not qualify if:

• Consent not provided
• Patients less than 18 years of age, or 90 years of age or older.
• Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.
• Patients that are not located in the designated medical or surgical ward associated with the study.
• Patients listed for "Comfort Measures Only".
• Less than 2 SIRS criteria
• Commencement of narrow spectrum directed antibiotics prior to screening.

Sponsors & Collaborators

• Immunexpress: lead
• Rhode Island Hospital: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Links

• Sponsor's website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and plasma specimens for nucleic acid and protein analysis

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchell Levy, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Steven Opal, MD

  Memorial Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 10, 2016
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: February 1, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)