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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03583762
Enrollment
200
Registered
2018-07-11
Start date
2018-07-30
Completion date
2019-03-31
Last updated
2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septicemia

Keywords

Microarray Assay Technique, Mass Spectrometry Technique, Time to appropriate antibiotic

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.

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

Sponsors

Chiang Mai University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* Suspected contaminated positive blood culture * Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations * Terminally ill patients

Design outcomes

Primary

MeasureTime frameDescription
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 Cultures4 days from positive hemocultureComparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)

Secondary

MeasureTime frameDescription
Mortality rate at 2 weeks14 days from positive hemocultureTo compare proportion of mortality between 2 study periods (Mass spectrometry technique and Microarray assay group) at 2 weeks after enrollment
Length of hospital stays30 daysTo compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)
Cost of antibiotic therapy14 daysTo 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 antibiotic14 daysTo compare percentage of De-escalation or escalation antibiotic between 2 study periods (Mass spectrometry technique and Microarray assay group)

Countries

Thailand

Contacts

Primary ContactParichart Sakulkonkij, MD
papi-jung@hotmail.com+66-81595-8662
Backup ContactParichat Salee, MD
parichat.pimsarn@gmail.com+66-5393-6457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026