Actionable Results: Bloodstream Infection Molecular Assay Evaluation

NCT03255759 | Completed DMC

• 1 other identifier: 08821/1/1
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  1year

Secondary Outcomes (8)

• Time from blood collection to initiation of effective antimicrobial therapy (initiation of antimicrobials active against the identified causative pathogen)

  1year

• Time from blood collection to pathogen identification

  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.

  1year

• Frequency of discrepant results between molecular identification vs standard of care.

  1year

• Clinicians' satisfaction with the assay, predominantly in terms of time-to-result and actionable results.

  2month

Study Arms (2)

Molecular dx arm

ACTIVE COMPARATOR

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

Standard of care arm

NO INTERVENTION

Positive blood cultures are treated as per normal lab protocol (biochemical identification)

Interventions

Multiplex molecular diagnostic assay DIAGNOSTIC_TEST

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.

Molecular dx arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Pernica, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

• David Goldfarb, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: May 24, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

BO (1)