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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

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date July 11, 2018
Estimated Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique
Official Title  ICMJE Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Septicemia
Intervention  ICMJE
  • Diagnostic Test: Mass spectrometry
    Molecular diagnostic test for bacterial identification from bacterial colony
  • 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
Study Arms  ICMJE
  • Experimental: Pre-intervention group
    100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique
    Intervention: Diagnostic Test: Mass spectrometry
  • 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
    Intervention: Diagnostic Test: Microarray assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Parichart Sakulkonkij, MD +66-81595-8662 papi-jung@hotmail.com
Contact: Parichat Salee, MD +66-5393-6457 parichat.pimsarn@gmail.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583762
Other Study ID Numbers  ICMJE MED-2561-05383
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Romanee Chaiwarith, Chiang Mai University
Study Sponsor  ICMJE Chiang Mai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Parichart Sakulkonkij, MD Chiang Mai University
PRS Account Chiang Mai University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP