Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique

Study Overview
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Brief Summary
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This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification.

Detailed Description
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Between June to Dec 2018, 200 participants those met the eligibility criteria were enrolled in this study that is a quasi experimental study. All participants were empirical antibiotic therapy by infectious physician. 100 patients in Pre-intervention group had bacterial identification by Mass spectrometry technique from bacterial colony and 100 patients in Post-intervention group had bacterial identification by Microarray assay from blood culture. Antibiotic adjustment were considered after bacterial identification and result of antibiotic susceptibility testing. Then all participants were re-evaluated outcome after treatment. Finally, the results were ready to analysis in January 2019.

Official Title
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Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures

Conditions
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Septicemia

Intervention / Treatment
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* Diagnostic Test: Mass spectrometry
* Diagnostic Test: Microarray assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 year old with positive hemoculture between June 2018 and Dec 2018 Internal medicine wards patients at Maharaj Nakorn Chiang Mai Hospital Ability to provide informed consent Exclusion Criteria: Suspected contaminated positive blood culture Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations Terminally ill patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-intervention group<br>100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique | Diagnostic Test: Mass spectrometry<br>* Molecular diagnostic test for bacterial identification from bacterial colony<br>|
| Experimental: Post-intervention group<br>100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique | Diagnostic Test: Microarray assay<br>* Bacterial identification by Microarray assay from positive blood culture and confirmed by Mass spectrometry technique from bacterial colony. Adjusted antibiotic therapy according to AST Re-evaluation after treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures | Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group) | 4 days from positive hemoculture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate at 2 weeks | To compare proportion of mortality between 2 study periods (Mass spectrometry technique and Microarray assay group) at 2 weeks after enrollment | 14 days from positive hemoculture | 
| Length of hospital stays | To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group) | 30 days | 
| Cost of antibiotic therapy | To compare the cost of antibiotics for the course of treatment during study period between 2 study period (Mass spectrometry technique and Microarray assay group) | 14 days | 
| Percentage of De-escalation or escalation antibiotic | To compare percentage of De-escalation or escalation antibiotic between 2 study periods (Mass spectrometry technique and Microarray assay group) | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microarray Assay Technique, Mass Spectrometry Technique, Time to appropriate antibiotic