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

C

Caen University Hospital

Status

Completed

Conditions

Bloodstream Infection

Treatments

Procedure: Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full description

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.

Enrollment

302 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

302 participants in 2 patient groups

Multi-sampling strategy
Experimental group
Description:
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.
Treatment:
Procedure: Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia
Single-sampling strategy
Active Comparator group
Description:
1 single dose of venous blood 30ml ± 10ml with seeding 4 blood culture bottles (aerobic and anaerobic 2 2).
Treatment:
Procedure: Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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