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

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



Sponsors

Lead Sponsor



Source

Chiang Mai University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-07-30

Completion Date

2019-03-31

Primary Completion Date

2018-12-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

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
4 days from positive hemoculture

Secondary Outcome

Measure

Time Frame

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

Enrollment

200

Condition


Intervention

Intervention Type

Diagnostic Test

Intervention Name


Description

Molecular diagnostic test for bacterial identification from bacterial colony

Arm Group Label

Pre-intervention group


Intervention Type

Diagnostic Test

Intervention Name


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

Arm Group Label

Post-intervention group



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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Parichart Sakulkonkij, MD
Principal Investigator
Chiang Mai University

Overall Contact

Last Name

Parichart Sakulkonkij, MD

Phone

+66-81595-8662

Email

papi-jung@hotmail.com


Location

Facility

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

Location Countries

Country

Thailand


Verification Date

2018-07-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Chiang Mai University

Investigator Full Name

Romanee Chaiwarith

Investigator Title

Associate Professor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Anti-Bacterial Agents

Antibiotics, Antitubercular



Arm Group

Arm Group Label

Pre-intervention group

Arm Group Type

Experimental

Description

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


Arm Group Label

Post-intervention group

Arm Group Type

Experimental

Description

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



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Parichat Salee, MD

Phone

+66-5393-6457

Email

parichat.pimsarn@gmail.com


Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Sequential Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

June 15, 2018

Study First Submitted Qc

July 10, 2018

Study First Posted

July 11, 2018

Last Update Submitted

July 10, 2018

Last Update Submitted Qc

July 10, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on August 29, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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