NCT03255759

Actionable Results: Bloodstream Infection Molecular Assay Evaluation

Completed NA Last updated 10 March 2021

What this trial tests

NA trial testing Multiplex molecular diagnostic assay in Bloodstream Infection in 312 participants. Completed in 31 March 2020.

Timeline

24 May 2018

Primary endpoint
31 March 2020

31 March 2020

Quick facts

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	312
Start date	24 May 2018
Primary completion	31 March 2020
Estimated completion	31 March 2020
Sites	1 location across Botswana

Drugs / interventions tested

• Multiplex molecular diagnostic assay

Conditions studied

• Bloodstream Infection — all drugs for Bloodstream Infection →

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Who can join

Eligibility, any sex, with Bloodstream Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cost-effectiveness of molecular diagnostic assays for the therapy of severe sepsis and septic shock in the emergency department.
   Zacharioudakis IM, Zervou FN, Shehadeh F, Mylonakis E. · · 2019 · cited 9× · PMID 31125382 · DOI 10.1371/journal.pone.0217508