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

Chiang Mai University

Status: Unknown

Conditions: Septicemia

Treatments: Diagnostic Test: Microarray assay; Diagnostic Test: Mass spectrometry

Study type: Interventional

Funder types: Other

Identifiers

NCT03583762

MED-2561-05383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pre-intervention group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Mass spectrometry

Post-intervention group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Microarray assay