Status:

COMPLETED

Actionable Results: Bloodstream Infection Molecular Assay Evaluation

Lead Sponsor:

Foundation for Innovative New Diagnostics, Switzerland

Conditions:

Bloodstream Infection

Eligibility:

All Genders

Phase:

NA

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...

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 antibioti...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 24 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2020

Estimated Enrollment :

312 Patients enrolled

Trial Details

Trial ID

NCT03255759

Start Date

May 24 2018

End Date

March 31 2020

Last Update

March 10 2021

Active Locations (1)

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Princess Marina Hospital

Gaborone, Botswana