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

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

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.

Study Overview

• Status: Unknown
• Conditions: Septicemia
• Intervention / Treatment: Diagnostic test: Mass spectrometry; Diagnostic test: Microarray assay

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Parichart Sakulkonkij, MD; Phone Number: +66-81595-8662; Email: papi-jung@hotmail.com
• Study Contact Backup: Name: Parichat Salee, MD; Phone Number: +66-5393-6457; Email: parichat.pimsarn@gmail.com

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-intervention group; 100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique	Diagnostic test: Mass spectrometry; Molecular diagnostic test for bacterial identification from bacterial colony
Experimental: Post-intervention group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Parichart Sakulkonkij, MD, Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Microarray Assay Technique; Mass Spectrometry Technique; Time to appropriate antibiotic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: MED-2561-05383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No