MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
NCT ID: NCT02306330
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
802 participants
INTERVENTIONAL
2014-12-31
2016-01-31
Brief Summary
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Detailed Description
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Allocation to diagnostic arm will be assigned by a web based randomization program. When a pathogen is isolated from a positive eligible specimen, the laboratory technician will log onto the secure randomization program and enter the patient and specimen code. The random diagnostic pipeline allocation will then be generated, informed to the laboratory technician and logged in the study database. In the case of multiple specimens with pathogen growth for a single patient, the unique patient code will trigger the randomization program to generate the same diagnostic arm allocation as the previous sample(s).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Malditof
Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in Malditof arm will be performed by Malditof instrument to identify the pathogens. It takes 20 minutes for Malditof to identify the pathogens. Then patients will be treated based on these results.
Malditof
Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.
Routine clinical microbiology
Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in routine clinical microbiology arm will be conducted by the routine clinical microbiologies and followed the treatment process of the hospital.
Routine clinical microbiology
Pathogens will be identified by the routine clinical microbiology of the hospital.
Interventions
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Malditof
Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.
Routine clinical microbiology
Pathogens will be identified by the routine clinical microbiology of the hospital.
Eligibility Criteria
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Exclusion Criteria
ALL
No
Sponsors
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National Hospital for Tropical Diseases, Hanoi, Vietnam
OTHER_GOV
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
OTHER
Oxford University Clinical Research Unit, Vietnam
OTHER
Responsible Party
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Principal Investigators
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Heiman Wertheim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oxford University of Clinical Research
Locations
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National Hospital for Tropical Diseases
Hà Nội, , Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, , Vietnam
Countries
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References
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Nadjm B, Dat VQ, Campbell JI, Dung VTV, Torre A, Tu NTC, Van NTT, Trinh DT, Lan NPH, Trung NV, Hang NTT, Hoi LT, Baker S, Wolbers M, Chau NVV, Van Kinh N, Thwaites GE, van Doorn HR, Wertheim HFL. A randomised controlled trial of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDITOF-MS) versus conventional microbiological methods for identifying pathogens: Impact on optimal antimicrobial therapy of invasive bacterial and fungal infections in Vietnam. J Infect. 2019 Jun;78(6):454-460. doi: 10.1016/j.jinf.2019.03.010. Epub 2019 Mar 23.
Related Links
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Oxford University Clinical Research Unit Viet Nam
Other Identifiers
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09HN
Identifier Type: -
Identifier Source: org_study_id