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
About this trial
This is an interventional diagnostic trial for Bloodstream Infection focused on measuring Blood culture, Bacteremia, Single sampling
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
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
NCT ID
NCT02516514
First Posted
July 28, 2015
Last Updated
August 4, 2015
Sponsor
University Hospital, Caen
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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