Clinical trial NCT02704871: The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sepsis
SIRS
Keywords: SeptiCyte
Lead sponsor: Immunexpress
Sponsor class: INDUSTRY
Collaborators: name: Rhode Island Hospital
First posted: 2016-03-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SeptiCyte® Lab test result versus Retrospective Physician Diagnosis (RPD) result
timeFrame: 7 days
Secondary outcomes:
measure: SeptiCyte® Lab test result versus test results for other sepsis biomarkes, including leukocytosis, bandemia, & procalcitonin
timeFrame: 7 days
Other outcomes:
measure: SeptiCyte® Lab test result versus a generalized sepsis screening protocol for identifying potential cases of sepsis
timeFrame: 1 day
measure: SeptID® test result versus microbiological reference methods for identifying pathogen(s)
timeFrame: 7 days
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Mitchell Levy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Hospital of Rhode Island
name: Steven Opal, MD
role: PRINCIPAL_INVESTIGATOR
References: