Clinical trial NCT06241248: Evaluation of the Performance of a New Rapid Bacteremia Test in the Intensive Care Patient
Official title: Evaluation of the Performance of a New Rapid Bacteremia Test in the Intensive Care Patient
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: Intensive Care
Blood culture
Bacteremia
Rapid Diagnostic Tests
Antimicrobial resistance
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to an intensive care unit (ICU) with a suspected or documented infection requiring blood cultures

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison between OCEAN test and gold standard
timeFrame: 1 month after inclusion day
Secondary outcomes:
measure: Positivity rate
timeFrame: 1 month after inclusion day
measure: Delay of positivity
timeFrame: 1 month after inclusion day
measure: Impact of Ocean test on antibiotic therapy adaptation.
timeFrame: 1 month after inclusion day
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital Haut-Lévêque
Study officials:
References: