Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

Sepsis Clinical Trial

— BACTIDIAG  

Official title:

Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721134
• Other study ID #: 14-PP-18
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 17, 2020

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 17, 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Antibes hospital Center	Antibes
France	Cannes Hospital	Cannes
France	Draguignan Hospital	Draguignan
France	Frejus Hospital	Fréjus
France	CHU de Nice	Nice
Monaco	Monaco princesse grace Hospital	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Bio-Rad Laboratories

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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