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

Primary Purpose

Bloodstream Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bloodstream Infection focused on measuring Blood culture, Bacteremia, Single sampling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multi-sampling strategy

    Single-sampling strategy

    Arm 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.

    1 single dose of venous blood 30ml ± 10ml with seeding 4 blood culture bottles (aerobic and anaerobic 2 2).

    Outcomes

    Primary Outcome Measures

    Rate of pathogens identified by each strategy

    Secondary Outcome Measures

    Proportion of blood cultures contaminated in each strategy

    Full Information

    First Posted
    July 28, 2015
    Last Updated
    August 4, 2015
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02516514
    Brief Title
    The Only Blood Culture for Diagnosis of Bacteremia - Comparative Study of Practice
    Acronym
    HEMU
    Official Title
    The Only Blood Culture for Diagnosis of Bacteremia - Comparative Study of Practice
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bloodstream Infection
    Keywords
    Blood culture, Bacteremia, Single sampling

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    302 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multi-sampling strategy
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Single-sampling strategy
    Arm Type
    Active Comparator
    Arm Description
    1 single dose of venous blood 30ml ± 10ml with seeding 4 blood culture bottles (aerobic and anaerobic 2 2).
    Intervention Type
    Procedure
    Intervention Name(s)
    Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia
    Intervention Description
    Comparison between two strategies of blood culture (single-sampling strategy and multi-sampling strategy) for the diagnosis of bacteremia
    Primary Outcome Measure Information:
    Title
    Rate of pathogens identified by each strategy
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Proportion of blood cultures contaminated in each strategy
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15227618
    Citation
    Cockerill FR 3rd, Wilson JW, Vetter EA, Goodman KM, Torgerson CA, Harmsen WS, Schleck CD, Ilstrup DM, Washington JA 2nd, Wilson WR. Optimal testing parameters for blood cultures. Clin Infect Dis. 2004 Jun 15;38(12):1724-30. doi: 10.1086/421087. Epub 2004 May 25.
    Results Reference
    background
    PubMed Identifier
    7852579
    Citation
    Li J, Plorde JJ, Carlson LG. Effects of volume and periodicity on blood cultures. J Clin Microbiol. 1994 Nov;32(11):2829-31. doi: 10.1128/jcm.32.11.2829-2831.1994.
    Results Reference
    background
    PubMed Identifier
    9060065
    Citation
    Arendrup M, Jensen IP, Justesen T. Diagnosing bacteremia at a Danish hospital using one early large blood volume for culture. Scand J Infect Dis. 1996;28(6):609-14. doi: 10.3109/00365549609037969.
    Results Reference
    background
    PubMed Identifier
    12228821
    Citation
    Lamy B, Roy P, Carret G, Flandrois JP, Delignette-Muller ML. What is the relevance of obtaining multiple blood samples for culture? A comprehensive model to optimize the strategy for diagnosing bacteremia. Clin Infect Dis. 2002 Oct 1;35(7):842-50. doi: 10.1086/342383. Epub 2002 Sep 10.
    Results Reference
    background
    PubMed Identifier
    17881544
    Citation
    Lee A, Mirrett S, Reller LB, Weinstein MP. Detection of bloodstream infections in adults: how many blood cultures are needed? J Clin Microbiol. 2007 Nov;45(11):3546-8. doi: 10.1128/JCM.01555-07. Epub 2007 Sep 19.
    Results Reference
    background

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

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