The Only Blood Culture for Diagnosis of Bacteremia - Comparative Study of Practice

Study Overview
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Brief Summary
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Current recommendations for the diagnosis of bacteremia based on the embodiment February-March blood cultures separated by a minimum interval of 30 minutes. Each blood culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10 ml of blood. The sensitivity and specificity of this technique depends essentially on the amount of blood removed since there is a direct relationship between the volume of blood inoculated into each flask and the efficiency of the technique. A preliminary study conducted at the University Hospital of Caen found that 14-30% of patients depending on the services had received only one blood culture. In addition, at least four blood cultures in 24 hours were taken for 10 to 20% of patients. The practice of a single blood culture reduces the sensitivity of the analysis due to insufficient total amount of blood collected. The practice of too many blood cultures increases the risk of false positive (presence of contaminating bacteria), generates extra work for healthcare personnel (and laboratory) and represents a significant cost for an unproven benefit. The investigators propose to evaluate a single blood culture sampling technique with seeding 4 vials (2 aerobic and anaerobic 2).

Detailed Description
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Blood cultures will be collected from patients admitted with on of the following signs: fever (≥38.5°C), hypothermia (≤36°C), chills or shock. For the first blood culture, 40 mL of blood will be obtained aseptically by a single phlebotomy and equally distributed into two BacT/Alert FA aerobic bottles and two BacT/Alert FN anaerobic bottles (bioMérieux, La-Balme-les-Grottes, France). The four bottles will be labelled from one to four in the following order: aerobic-anaerobic-aerobic-anaerobic. Within the next 24 h, one to three other 20-mL blood cultures consisting of a single pair of aerobic and anaerobic bottles will have to be performed, spaced by a minimum of 30 minutes. Bottles will be incubated for 5 days or until positivity reported by the BacT/Alert 3D instrument.

Official Title
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The Only Blood Culture for Diagnosis of Bacteremia - Comparative Study of Practice

Conditions
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Bloodstream Infection

Intervention / Treatment
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* Procedure: Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is at least 18 years Patients admitted to an emergency department of a three CHU Caen, Lille, Rouen Patient with clinical justifying the realization of blood cultures (as good practice recommendations) Patients who received information about the study or if his legal representatives or his close entourage Patient not objecting to the venipuncture Exclusion Criteria: Patient who direct venipuncture is impossible Patient refusing venipuncture Patient aged under 18 Patient with impaired vigilance and not accompanied by a family member or a trusted person may receive clear information protocol Vulnerable Patient and not accompanied by a family member or a trusted person may receive clear information protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-sampling strategy<br>2 or 3 blood cultures in 24 hours worked at ½ hour intervals with seeding at least a pair of flasks, aerobic and anaerobic, by blood culture. | Procedure: Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia<br>* Comparison between two strategies of blood culture (single-sampling strategy and multi-sampling strategy) for the diagnosis of bacteremia<br>|
| Active Comparator: Single-sampling strategy<br>1 single dose of venous blood 30ml ± 10ml with seeding 4 blood culture bottles (aerobic and anaerobic 2 2). | Procedure: Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia<br>* Comparison between two strategies of blood culture (single-sampling strategy and multi-sampling strategy) for the diagnosis of bacteremia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pathogens identified by each strategy |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of blood cultures contaminated in each strategy |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood culture, Bacteremia, Single sampling