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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedStudy Start
First participant enrolled
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedJuly 11, 2018
July 1, 2018
5 months
June 15, 2018
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Mortality rate at 2 weeks
14 days from positive hemoculture
Length of hospital stays
30 days
Cost of antibiotic therapy
14 days
Percentage of De-escalation or escalation antibiotic
14 days
Study Arms (2)
Pre-intervention group
EXPERIMENTAL100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique
Post-intervention group
EXPERIMENTAL100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique
Interventions
Molecular diagnostic test for bacterial identification from bacterial colony
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Suspected contaminated positive blood culture
- Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations
- Terminally ill patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Chiang Mai, 50200, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parichart Sakulkonkij, MD
Chiang Mai University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 15, 2018
First Posted
July 11, 2018
Study Start
July 30, 2018
Primary Completion
December 31, 2018
Study Completion
March 31, 2019
Last Updated
July 11, 2018
Record last verified: 2018-07