Actionable Results: Bloodstream Infection Molecular Assay Evaluation

Foundation for Innovative New Diagnostics (FIND)

Status

Completed

Conditions

Bloodstream Infection

Treatments

Diagnostic Test: Multiplex molecular diagnostic assay

Study type

Interventional

Funder types

Other

Identifiers

NCT03255759

08821/1/1

Details and patient eligibility

About

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.

Full description

The study will address the following questions:

What impact can we project if additional diagnostic information were to be provided to clinicians in terms of patient outcomes, costs, and antibiotic use?
What are the workflow constraints on returning diagnostic results to clinicians and/or antibiotic stewardship programs? Overall, the aim 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.

Enrollment

312 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

For patients of Princess Marina Hospital: all participants who have a blood culture done as part of routine clinical care that is found to be positive through routine laboratory testing from Monday-Friday 8am-3pm (excluding holidays) will be eligible for inclusion in the study, regardless of age and co-morbidities.
For the professionals making use of molecular testing: Attending physicians (paediatricians, internists, and physician trainees [residents, medical officers, interns]) caring for adults and children who are enrolled in the study, Microbiologists and microbiology technologists who have experience operating the BioFire FilmArray and/or traditional blood culture incubation systems at the laboratory.

Exclusion criteria

For patients of Princess Marina Hospital: Individuals who have previously participated in the study by having a blood culture positive in the week prior will not be eligible to participate again within the 7-day time frame.
For professionals making use of molecular testing: Individuals working with patients or laboratory samples at Princess Marina Hospital for less than one month will not be asked to participate.