Trial document




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  DRKS00015813

Trial Description

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Title

Prospective Comparison of four antimicrobial susceptibility testing methods ( Biomerieux VITEK 2, Liofilchem MIC Test Strips, Merlin MICRONAUT MIC-Strip, Bio Rad Susceptibility Disks ) to determine in vitro activitiy of Piperacillin/Tazobactam against Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa in blood culture isolates

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Trial Acronym

BK Tazo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The antibiotic piperacillin / tazobactam plays a significant role in the treatment of bloodstream infections. For this reason, an exact determination of the smallest concentration of the active substance which prevents pathogen propagation is of great importance. This study compares four different sensitivity testing procedures. The test procedures are microdilution, the Vitek automatic test system, the Epsilometer test and the agar diffusion tests. We test 150 bacterial strains of Escheria coli, Klebsiella pneumonia and Pseudomonas aeruginosa from blood culture isolates. The interpreted measurement results are compared.

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Brief Summary in Scientific Language

Piperacillin in combination with the beta-lactamase inhibitor tazobactam is commonly used in the treatment of bloodstream infection. Therefore, the antimicrobial susceptibility testing (AST) of Piperacillin / tazobactam is a critical step in the management of bloodstream infections.
Our objective is to compare the performance of four commonly used, methodically different antimicrobial susceptibility testing systems Biomerieux VITEK 2 AST 248, Liofilchem MIC Test Strips, Merlin MICRONAUT MIC-Strip, Bio Rad Antimicrobial Susceptibility Disks. Therefore, we prospectively test and compare the results of the three most common Gram-negative pathogens from positive blood cultures. A total of 150 isolates, including Escherichia coli (n=50), Klebsiella pneumoniae (n=50) and Pseudomonas aeruginosa (n=50) were recovered from our collection of positive blood culture isolates. Categories of susceptibility yielded from each method are interpreted according to EUCAST and CSLI-breakpoints. The level of categorical agreement between each of the methods is analyzed. Further the minimum inhibitory concentration are compared and subgroup analyses for each pathogen are performed.

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Organizational Data

  •   DRKS00015813
  •   2018/11/15
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   [---]*, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  •   U1111-1224-0035 
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Health Condition or Problem studied

  •   A41.51 -  [generalization A41.5: Sepsis due to other Gram-negative organisms]
  •   A41.52 -  [generalization A41.5: Sepsis due to other Gram-negative organisms]
  •   A41.58 -  [generalization A41.5: Sepsis due to other Gram-negative organisms]
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Interventions/Observational Groups

  •   Measurement of the minimum inhibitory concentration (MIC) for piperacillin / tazobactam with Biomerieux VITEK 2 AST 248
  •   Measurement of the minimum inhibitory concentration (MIC) for piperacillin / tazobactam with Liofilchem MIC Test Strips
  •   Measurement of the minimum inhibitory concentration (MIC) for piperacillin / tazobactam with Merlin MICRONAUT MIC-Strip
  •   Measurement of the minimum inhibitory concentration (MIC) for piperacillin / tazobactam with Bio Rad Susceptibility Disks
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   No
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Primary Outcome

Categorical agreement between each of the methods for Piperacillin/Tazobactam based on EUCAST

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Secondary Outcome

Categorical agreement between each of the methods for Piperacillin/Tazobactam based on CLSI. Comparison of the minimum inhibitory concentration

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/10/26
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Blood cultures isolates with Escheria coli, Klebsiella pneumonia and Pseudomonas aeruginosa found at the University Hospital Bonn from 2016 to 2018.

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Exclusion Criteria

From each patient only one isolate is included.

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Addresses

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie
    • Mr.  Thomas  Gehring 
    • Sigmund-Freud-Straße 25
    • 53127  Bonn
    • Germany
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    • Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie
    • Mr.  Thomas  Gehring 
    • Sigmund-Freud-Straße 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie
    • Mr.  Thomas  Gehring 
    • Sigmund - Freud - Straße 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/20
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.