Evaluation of the Performance of a New Rapid Bacteremia Test in the Intensive Care Patient

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

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-13

Study Completion Date

2025-06-10

Brief Summary

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Sepsis is a serious health problem with a very high mortality in the ICU. The most important treatment for sepsis is the fastest possible antibiotic therapy. The identification of the pathogen responsible for sepsis is essential to propose an appropriate antibiotic treatment. However, the diagnosis of bacteremia by blood culture requires an average delay of 48 to 72 hours. The new test proposed by OCEAN Dx makes it possible to identify a bacteremia in a few hours. The main objective of the study is to evaluate the performance of the rapid identification test for bacteremia proposed by OCEAN Dx compared to a classic diagnostic strategy using blood cultures.

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Detailed Description

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Sepsis is a worldwide problem. The World Health Organization estimates that around 49 million people suffer from sepsis each year. It is responsible for an unacceptable number of deaths, estimated at around 11 million. The severity of sepsis is not only related to the infection itself, but often to a too late diagnosis and an important heterogeneity in the management of patients. The identification of the pathogen responsible for sepsis is currently based on the positivity of bacteriological samples, particularly blood cultures. However, the diagnosis of bacteremia by blood cultures requires an average delay of 48 to 72 hours, which is not conducive to rapid adaptation of antibiotic therapy. The test proposed by OCEAN Dx offers the identification of a bacteremia in a few hours thanks to the recognition of the bacterial DNA in the patient's blood. The main objective of the study is to evaluate the performance of the rapid identification test for bacteremia offered by OCEAN Dx in comparison with a classical diagnostic strategy using blood cultures.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ocean Test

The OCEAN Dx tests for the diagnosis of sepsis will be performed on 9 milliliters of blood collected at the patient's bedside.The sample will be collected at the same time as the blood cultures are taken. The blood tubes will then be transported to OCEAN Dx laboratories.

Rapid sepsis diagnostic test

Intervention Type DIAGNOSTIC_TEST

The different stages of the OCEAN Dx whole blood bacterial identification test. Identification is carried out using 9 ml of whole blood taken at the patient's bedside, and is provided after comparing the DNA sequence of the bacteria with a database. The rapid sepsis diagnostic test developed by OCEAN Dx can identify the bacteria responsible for the infection in just 4 hours at present, and soon in 3 hours. Subject to future innovations, it will probably even be possible to obtain a positive result for the presence of bacteria in the patient's sample in just 2 hours.

Interventions

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Rapid sepsis diagnostic test

The different stages of the OCEAN Dx whole blood bacterial identification test. Identification is carried out using 9 ml of whole blood taken at the patient's bedside, and is provided after comparing the DNA sequence of the bacteria with a database. The rapid sepsis diagnostic test developed by OCEAN Dx can identify the bacteria responsible for the infection in just 4 hours at present, and soon in 3 hours. Subject to future innovations, it will probably even be possible to obtain a positive result for the presence of bacteria in the patient's sample in just 2 hours.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age admitted to an intensive care unit (ICU) with a suspected or documented infection requiring blood cultures.

Exclusion Criteria

* Patient under 18 years of age
* Pregnant or breastfeeding woman
* Patient of legal age, under guardianship or deprived of liberty
* Not affiliated to a social security regime or not benefiting from such a regime.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No