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Status unknownNCT03583762Updated Jul 11, 2018

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

An interventional study of Mass spectrometry and Microarray assay in Septicemia, sponsored by Chiang Mai University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.

Sponsored by Chiang Mai University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Septicemia

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Keywords

  • Microarray Assay Technique
  • Mass Spectrometry Technique
  • Time to appropriate antibiotic
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 200 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Pre-intervention group

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

    Diagnostic Test: Mass spectrometry

  • 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

Interventions

  • Diagnostic testMass spectrometry

    Molecular diagnostic test for bacterial identification from bacterial colony

  • Diagnostic testMicroarray 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

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What researchers measure

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)

    Time frame: 4 days from positive hemoculture

Secondary outcomes

  1. 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

    Time frame: 14 days from positive hemoculture

  2. Length of hospital stays

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

    Time frame: 30 days

  3. 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)

    Time frame: 14 days

  4. 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)

    Time frame: 14 days

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Study locations

1 site
  • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
    Chiang Mai, 50200, Thailand
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03583762
Lead sponsor
Chiang Mai University
Responsible party
Romanee Chaiwarith (Associate Professor, Chiang Mai University) — Principal investigator
First posted
Jul 11, 2018
Start date
Jul 30, 2018 (estimated)
Primary completion
Dec 31, 2018 (estimated)
Completion
Mar 31, 2019 (estimated)
Last update
Jul 11, 2018

Study contacts

Parichart Sakulkonkij, MD
Contact
papi-jung@hotmail.com
+66-81595-8662
Parichat Salee, MD
Contact
parichat.pimsarn@gmail.com
+66-5393-6457
Parichart Sakulkonkij, MD
principal investigator · Chiang Mai University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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