Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: additional blood tubes

• Registration Number: NCT02721134
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Primary Completion: 2018-05
• Study Completion: 2020-11-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
additional blood tubes	additional blood tubes	-

Primary Outcome Measures

Name	Time	Method
determine the AUC	2 years	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

Trial Locations

Locations (6)

Cannes Hospital; 🇫🇷 Cannes, France

Antibes hospital Center; 🇫🇷 Antibes, France

Draguignan Hospital; 🇫🇷 Draguignan, France

Frejus Hospital; 🇫🇷 Fréjus, France

CHU de Nice; 🇫🇷 Nice, France

Monaco princesse grace Hospital; 🇲🇨 Monaco, Monaco