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

Septicemia Clinical Trial

Official title:

Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03583762
• Other study ID #: MED-2561-05383
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2018
• Source: Chiang Mai University
• Contact: Parichart Sakulkonkij, MD
• Phone: +66-81595-8662
• Email: papi-jung[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septicemia

Intervention

Diagnostic Test:
• Mass spectrometry
Molecular diagnostic test for bacterial identification from bacterial colony
• 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

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	4 days from positive hemoculture
Secondary	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	14 days from positive hemoculture
Secondary	Length of hospital stays	To compare lengths of hospital stay between 2 study periods (Mass spectrometry technique and Microarray assay group)	30 days
Secondary	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)	14 days
Secondary	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)	14 days