Clinical trial NCT02721134: Diagnostic Performance of a New Bio-marker During Bacterial Sepsis
Official title: Diagnostic Performance of a New Bio-marker During Bacterial Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Bio-Rad Laboratories
First posted: 2016-03-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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)

Primary outcomes:
measure: determine the AUC
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antibes
country: France
facility: Antibes hospital Center
city: Cannes
country: France
facility: Cannes Hospital
city: Draguignan
country: France
facility: Draguignan Hospital
city: Fréjus
country: France
facility: Frejus Hospital
city: Nice
country: France
facility: CHU de Nice
city: Monaco
country: Monaco
facility: Monaco princesse grace Hospital
Study officials:
References: