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Actionable Results: Bloodstream Infection Molecular Assay Evaluation

NCT03255759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

  • Bloodstream Infection

Interventions

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.

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Jeffrey Pernica, MD, FRCPC · McMaster University

  • David Goldfarb, MD, FRCPC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Botswana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255759 on ClinicalTrials.gov