NCT03255759

Actionable Results: Bloodstream Infection Molecular Assay Evaluation

Assessment of the Use and Impact of a Molecular Identification Assay in the Diagnosis and Management of Bloodstream Infections at in Healthcare Settings in Princess Marina Hospital, Botswana

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will address the following questions: 1. What impact can we project if additional diagnostic information were to be provided to clinicians in terms of patient outcomes, costs, and antibiotic use? 2. 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.

Conditions

• Bloodstream Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multiplex molecular diagnostic assay	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.

Timeline

• Start date: 2018-05-24
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2017-08-21
• Last updated: 2021-03-10

Locations

1 site across 1 country: Botswana