NCT02721134

Brief Summary

Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and prompt implementation of the etiological treatment. The bacterial infections are the most common and are associated with high morbidity and mortality. Diagnosis is based on the detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis, gram + and gram - are circulating and often present in small amounts; they can be detected by sensitive and specific tools following a pretreatment of the blood sample (innovative technology Bacti-DIAG). The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams) in the patient's care including diagnosis and treatment. All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS) sepsis suspects will be included: in addition to the samples taken for routine care of the patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas under the ROC curves for the detection of gram + and gram will be calculated and associated detection limits will be determined to meet the objectives of the study. It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and analyze biometric and biological data based on the subsequent evolution of the patients. The care of patients will be blinded to the results of the new biomarker Bacti-DIAG

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable sepsis

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

March 7, 2016

Last Update Submit

March 17, 2022

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • determine the AUC

    determine the AUC of a test ( Bacti DIAG ) for the diagnosis of sepsis and sepsis Gram + Gram - relative to the composite gold standard . Two analyzes will be performed , one for the diagnosis of sepsis Gram + and to that of sepsis Gram . We describe below the analysis to be conducted on Gram + diagnosis , it will suffice to transpose the study of Gram

    2 years

Study Arms (1)

additional blood tubes

OTHER
Other: additional blood tubes

Interventions

additional blood tubesOTHER

four whole blood tubes 5 ml (2 + EDTA tubes separating gel and dry tubes 2 + separating gel ) will be taken in order to assay more bacterial biomarkers on day 0 , J1, J2, J3 and J5

additional blood tubes

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> = 18 years
  • Patient hospitalized in ICU with a diagnosis of SIRS:
  • Temperatures above 38 ° C or below 36 ° C
  • At least one other criterion from:
  • Heart rate\> 90 bpm
  • Respiratory rate above 20 breaths / min or PaCO2 \<32 mmHg
  • Leukocytosis greater than or less than 4000/mm3 12000/m3
  • Patient admitted in intensive care for less than 12 hours
  • Patient does not preclude its participation in the study.

You may not qualify if:

  • No affiliation to a social security scheme (beneficiary or assignee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Antibes hospital Center

Antibes, 06600, France

Location

Cannes Hospital

Cannes, 06400, France

Location

Draguignan Hospital

Draguignan, 83300, France

Location

Frejus Hospital

Fréjus, 83600, France

Location

CHU de Nice

Nice, France

Location

Monaco princesse grace Hospital

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 29, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

November 17, 2020

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)FR(5)