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

• ClinicalTrials.gov Identifier: NCT03583762
• Recruitment Status: Unknown
• First Posted: July 11, 2018
• Last Update Posted: July 11, 2018
• Sponsor: Chiang Mai University
• Information provided by (Responsible Party): Romanee Chaiwarith, Chiang Mai University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Septicemia	Diagnostic Test: Mass spectrometry; Diagnostic Test: Microarray assay	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures
• Estimated Study Start Date: July 30, 2018
• Estimated Primary Completion Date: December 31, 2018
• Estimated Study Completion Date: March 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pre-intervention group; 100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique	Diagnostic Test: Mass spectrometry; Molecular diagnostic test for bacterial identification from bacterial colony
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; 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

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 4 days from positive hemoculture ]
   Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)

Secondary Outcome Measures :

1. Mortality rate at 2 weeks [ Time Frame: 14 days from positive hemoculture ]
   To compare proportion of mortality between 2 study periods (Mass spectrometry technique and Microarray assay group) at 2 weeks after enrollment
2. Length of hospital stays [ Time Frame: 30 days ]
   To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)
3. Cost of antibiotic therapy [ Time Frame: 14 days ]
   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)
4. Percentage of De-escalation or escalation antibiotic [ Time Frame: 14 days ]
   To compare percentage of De-escalation or escalation antibiotic between 2 study periods (Mass spectrometry technique and Microarray assay group)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Parichart Sakulkonkij, MD; +66-81595-8662; papi-jung@hotmail.com

Contact: Parichat Salee, MD; +66-5393-6457; parichat.pimsarn@gmail.com

Locations

Thailand

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

Chiang Mai, Thailand, 50200

Sponsors and Collaborators

Chiang Mai University

Investigators

• Principal Investigator: Parichart Sakulkonkij, MD; Chiang Mai University

More Information

• Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT03583762
• Other Study ID Numbers: MED-2561-05383
• First Posted: July 11, 2018
• Last Update Posted: July 11, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Romanee Chaiwarith, Chiang Mai University:

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

Additional relevant MeSH terms:

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes