Status:
COMPLETED
MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
National Hospital for Tropical Diseases, Hanoi, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Conditions:
Bacterial Infections
Fungal Infections
Eligibility:
All Genders
Phase:
NA
Brief Summary
MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an important new technology tha...
Detailed Description
When an eligible specimen from a patient shows pathogen growth, the pathogen identification will be randomized to either MaldiTof or routine diagnostics ('diagnostic pipelines'). Randomization to Mald...
Eligibility Criteria
Inclusion
- Pathogen isolates from the following specimens: blood or diagnostic aspirates from normally sterile sites (including cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies).
Exclusion
- Specimens negative for all pathogens
- Specimens from sputum, respiratory or non-surgical wound swabs, nails, mucosal or skin biopsies, urine, fluid from drains, skin swabs and any others not listed in the inclusion criteria.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
802 Patients enrolled
Trial Details
Trial ID
NCT02306330
Start Date
December 1 2014
End Date
January 1 2016
Last Update
November 15 2016
Active Locations (2)
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1
National Hospital for Tropical Diseases
Hà Nội, Vietnam
2
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam