Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-11-17

Brief Summary

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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

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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additional blood tubes

Group Type OTHER

additional blood tubes

Intervention Type OTHER

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

Interventions

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additional blood tubes

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.