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Trial record 1 of 751 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture
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Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique

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ClinicalTrials.gov Identifier: NCT03583762
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Romanee Chaiwarith, Chiang Mai University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583762


Contacts
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Contact: Parichart Sakulkonkij, MD +66-81595-8662 papi-jung@hotmail.com
Contact: Parichat Salee, MD +66-5393-6457 parichat.pimsarn@gmail.com

Locations
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Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Parichart Sakulkonkij, MD Chiang Mai University

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Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03583762     History of Changes
Other Study ID Numbers: MED-2561-05383
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents