Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

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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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antibes hospital Center, Antibes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

additional blood tubes

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

Primary outcomes

determine the AUC

Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

Bio-Rad Laboratories

Registry information

Acronym: BACTIDIAG

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2020
First posted: Mar 29, 2016
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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