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

NCT ID: NCT03583762

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2019-03-31

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.

Conditions

Septicemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-intervention group

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

Group Type: EXPERIMENTAL

Mass spectrometry

Intervention Type: DIAGNOSTIC_TEST

Molecular diagnostic test for bacterial identification from bacterial colony

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

Group Type: EXPERIMENTAL

Microarray assay

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Mass spectrometry

Molecular diagnostic test for bacterial identification from bacterial colony

Intervention Type: DIAGNOSTIC_TEST

Microarray 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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Romanee Chaiwarith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parichart Sakulkonkij, MD

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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

Chiang Mai, , Thailand

Countries

Thailand

Central Contacts

Parichart Sakulkonkij, MD

Role: CONTACT

papi-jung@hotmail.com

+66-81595-8662

Parichat Salee, MD

Role: CONTACT

parichat.pimsarn@gmail.com

+66-5393-6457

Other Identifiers

MED-2561-05383

Identifier Type: -

Identifier Source: org_study_id