Bacterial Infections Clinical Trial
Official title:
Assessing Time to Reporting and Clinical Management of Patients With Severe Bacterial and Fungal Infections Between Two Diagnostic Approaches: Matrix-assisted Laser Desorption Ionization-time of Flight Mass Spectrometry Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
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 that is becoming routine in developed countries. It is currently unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.
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 MaldiTof or routine diagnostics will be 1:1 with stratification by hospital
and specimen type (blood vs. other). Isolates grown from all eligible specimens of the same
patient will be assigned to the same diagnostic pipeline as the first randomized specimen of
that patient.
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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