An interventional study of Multiplex molecular diagnostic assay in Bloodstream Infection, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 1 site in Botswana. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Not applicable, Interventional, and Diagnostic
A number of rapid panel-based molecular assays for direct organism identification and resistance characterization in positive blood culture bottles are now commercially available. They have been shown to improve accuracy and decrease the time-to-result, allowing targeted treatment in hospitalized patients with bacteraemia, in high-income countries (HICs). However, these molecular assays are add-on tests performed in addition to conventional testing, increasing the complexity of diagnostic algorithms and costs of patient care. Conventional organism identification includes performing a Gram stain, biochemical identification and phenotypic drug susceptibility testing. The FilmArray Blood Culture Identification (BioFire, USA) is an example of a rapid panel-based molecular assay that combines nesting and multiplexing of PCR (nested multiplex PCR) to detect multiple pathogens simultaneously. There are limited data on how such tests impact patient management, health care costs and how they can better be incorporated into diagnostic algorithms.
The aim of this study is to assess the added value and acceptability of a multiplexed molecular diagnostic assay in the identification of pathogens in patients presenting with bacteremia at hospitals in LMICs, and to assess health care providers' satisfaction with the assay.
The study will address the following questions:
Exclusion Criteria:
Positive blood cultures are tested using a molecular ID system in addition to the standard of care (biochemical identification)
Diagnostic Test: Multiplex molecular diagnostic assay
Positive blood cultures are treated as per normal lab protocol (biochemical identification)
To assess the added value and acceptability of a multiplexed molecular diagnostic assay in the identification of pathogens in patients presenting with bacteremia at hospitals in LMICs, and to assess health care providers' satisfaction with the assay.
Time from blood collection to definitive treatment initiation (optimal treatment defined as time from blood culture collection to the initiation of a predetermined pathogen-specific antimicrobial therapy)
The judgment as to whether antimicrobial treatment was effective or optimal will be assessed by two members of the study team (infectious disease specialists and/or microbiologists) blinded to treatment group. A third, blinded, party member will be available to adjudicate unresolved disagreements. The Principal Investigators will not be involved in outcome classification.
Time frame: 1year
Time from blood collection to initiation of effective antimicrobial therapy (initiation of antimicrobials active against the identified causative pathogen)
The aim is to understand the reduction in time it takes clinical staff to act upon the result. Faster treatment is associated with reduced mortality.
Time frame: 1year
Time from blood collection to pathogen identification
The hypothesis is that faster identification will lead to faster action.
Time frame: 1year
Proportion of patients with a confirmed diagnosis of bloodstream infection who are started on optimal antimicrobial therapy in the intervention compared to control arm.
This outcome will inform how the inclusion of a faster diagnosis can support antibiotic stewardship efforts.
Time frame: 1year
Frequency of discrepant results between molecular identification vs standard of care.
Current panels are design for common pathogens in the USA and Europe and given that this is the first evaluation in Africa it will advice on the suitability.
Time frame: 1year
Clinicians' satisfaction with the assay, predominantly in terms of time-to-result and actionable results.
To inform future projects and help guide implementation efforts.
Time frame: 2month
Laboratory professional satisfaction with the assay, predominantly in terms of ease of use and workflow.
To inform future projects and help guide implementation efforts.
Time frame: 2month
In-hospital mortality.
Faster treatment is associated with reduced mortaltity and as a secondary outcome we want to assess the difference between standard of care and diagnostic intervention.
Time frame: 1year
30-day mortality.
Faster treatment is associated with reduced mortaltity and as a secondary outcome we want to assess the difference between standard of care and diagnostic intervention.
Time frame: 1year
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland