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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03583762
Other study ID # MED-2561-05383
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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