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

Primary Purpose

Septicemia

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Mass spectrometry
Microarray assay
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septicemia focused on measuring Microarray Assay Technique, Mass Spectrometry Technique, Time to appropriate antibiotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pre-intervention group

Post-intervention group

Arm Description

100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique

100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Length of hospital stays
To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)
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)
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)

Full Information

First Posted
June 15, 2018
Last Updated
July 10, 2018
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT03583762
Brief Title
Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique
Official Title
Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septicemia
Keywords
Microarray Assay Technique, Mass Spectrometry Technique, Time to appropriate antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention group
Arm Type
Experimental
Arm Description
100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique
Arm Title
Post-intervention group
Arm Type
Experimental
Arm Description
100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique
Intervention Type
Diagnostic Test
Intervention Name(s)
Mass spectrometry
Intervention Description
Molecular diagnostic test for bacterial identification from bacterial colony
Intervention Type
Diagnostic Test
Intervention Name(s)
Microarray assay
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)
Time Frame
4 days from positive hemoculture
Secondary Outcome Measure Information:
Title
Mortality rate at 2 weeks
Description
To compare proportion of mortality between 2 study periods (Mass spectrometry technique and Microarray assay group) at 2 weeks after enrollment
Time Frame
14 days from positive hemoculture
Title
Length of hospital stays
Description
To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)
Time Frame
30 days
Title
Cost of antibiotic therapy
Description
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)
Time Frame
14 days
Title
Percentage of De-escalation or escalation antibiotic
Description
To compare percentage of De-escalation or escalation antibiotic between 2 study periods (Mass spectrometry technique and Microarray assay group)
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parichart Sakulkonkij, MD
Phone
+66-81595-8662
Email
papi-jung@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Parichat Salee, MD
Phone
+66-5393-6457
Email
parichat.pimsarn@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parichart Sakulkonkij, MD
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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