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

Sepsis Clinical Trial

— OCEANIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241248
• Other study ID #: CHUBX 2023/28
• Status: Recruiting
• Start date: May 13, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Sepsis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Hopital Haut-Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between OCEAN test and gold standard	Agreement between the OCEAN Dx test results and blood cultures, gold standard of bacteriemia identification.	1 month after inclusion day
Secondary	Positivity rate	The positivity rate of the OCEAN Dx test and blood cultures	1 month after inclusion day
Secondary	Delay of positivity	Time to positivity of the OCEAN Dx test and blood cultures	1 month after inclusion day
Secondary	Impact of Ocean test on antibiotic therapy adaptation.	Cost of prescribed antibiotics and theoretical antibiotics after de-escalation according to the identification of germs by blood cultures and the OCEAN Dx test	1 month after inclusion day