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

NCT02516514 | Completed

• 1 other identifier: 10-033
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Bloodstream Infection

Keywords

Blood culture; Bacteremia; Single sampling

Outcome Measures

Primary Outcomes (1)

• Rate of pathogens identified by each strategy

  baseline

Secondary Outcomes (1)

• Proportion of blood cultures contaminated in each strategy

  baseline

Study Arms (2)

Multi-sampling strategy

EXPERIMENTAL

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

Single-sampling strategy

ACTIVE COMPARATOR

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

Interventions

Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia PROCEDURE

Comparison between two strategies of blood culture (single-sampling strategy and multi-sampling strategy) for the diagnosis of bacteremia

Multi-sampling strategy; Single-sampling strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Related Publications (5)

• 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.

  PMID: 15227618 BACKGROUND

• 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.

  PMID: 7852579 BACKGROUND

• 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.

  PMID: 9060065 BACKGROUND

• 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.

  PMID: 12228821 BACKGROUND

• 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.

  PMID: 17881544 BACKGROUND

MeSH Terms

Conditions

Sepsis; Bacteremia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 6, 2015
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 6, 2015

Record last verified: 2015-08