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

Not Applicable

• Conditions: Septicemia
• Interventions: Diagnostic Test: Microarray assay; Diagnostic Test: Mass spectrometry

• Registration Number: NCT03583762
• Lead Sponsor: Chiang Mai University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-15
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-10
• Last Update Submitted: 2018-07-10
• Study First Posted: 2018-07-11
• Last Update Posted: 2018-07-11
• Study Start: 2018-07-30
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Post-intervention group	Microarray assay	100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique
Pre-intervention group	Mass spectrometry	100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique

Primary Outcome Measures

Name	Time	Method
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	4 days from positive hemoculture	Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)

Secondary Outcome Measures

Name	Time	Method
Length of hospital stays	30 days	To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)
Cost of antibiotic therapy	14 days	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)
Mortality rate at 2 weeks	14 days from positive hemoculture	To compare proportion of mortality between 2 study periods (Mass spectrometry technique and Microarray assay group) at 2 weeks after enrollment
Percentage of De-escalation or escalation antibiotic	14 days	To compare percentage of De-escalation or escalation antibiotic between 2 study periods (Mass spectrometry technique and Microarray assay group)

Trial Locations

Locations (1)

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand