Bloodstream InfectionNCT03255759
Actionable Results: Bloodstream Infection Molecular Assay Evaluation
A study testing Multiplex molecular diagnostic assay in people with Bloodstream Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Botswana.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bloodstream Infection
- What is being tested?
- Multiplex molecular diagnostic assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteBotswana
- Study dates
- 24 May 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The study will address the following questions:
- What impact can we project if additional diagnostic information were to be provided to clinicians in terms of patient outcomes, costs, and antibiotic use?
- 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
- Being tested
- Multiplex molecular diagnostic assay
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex molecular diagnostic assayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Molecular dx arm | Active comparator | Positive blood cultures are tested using a molecular ID system in addition to the standard of care (biochemical identification) Receives: Diagnostic Test: Multiplex molecular diagnostic assay |
| Standard of care arm | No intervention | Positive blood cultures are treated as per normal lab protocol (biochemical identification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year
Secondary outcomes (8)
Time from blood collection to initiation of effective antimicrobial therapy (initiation of antimicrobials active against the identified causative pathogen)
The aim is to understand the reduction in time it takes clinical staff to act upon the result. Faster treatment is associated with reduced mortality.
Measured: 1year
Time from blood collection to pathogen identification
The hypothesis is that faster identification will lead to faster action.
Measured: 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.
This outcome will inform how the inclusion of a faster diagnosis can support antibiotic stewardship efforts.
Measured: 1year
Frequency of discrepant results between molecular identification vs standard of care.
Current panels are design for common pathogens in the USA and Europe and given that this is the first evaluation in Africa it will advice on the suitability.
Measured: 1year
Clinicians' satisfaction with the assay, predominantly in terms of time-to-result and actionable results.
To inform future projects and help guide implementation efforts.
Measured: 2month
Laboratory professional satisfaction with the assay, predominantly in terms of ease of use and workflow.
To inform future projects and help guide implementation efforts.
Measured: 2month
In-hospital mortality.
Faster treatment is associated with reduced mortaltity and as a secondary outcome we want to assess the difference between standard of care and diagnostic intervention.
Measured: 1year
30-day mortality.
Faster treatment is associated with reduced mortaltity and as a secondary outcome we want to assess the difference between standard of care and diagnostic intervention.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start24 May 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Pernica, MD, FRCPC, Principal investigator, McMaster UniversityDavid Goldfarb, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255759
- Sponsor's protocol ID
- 08821/1/1
- Status last verified
- Mar 2021
- First submitted
- 17 Aug 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03255759
- Acronym / sponsor ID
- 08821/1/1
- Conditions
- Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What impact can we project if additional diagnostic information were to be provided to clinicians in terms of patient outcomes, costs, and antibiotic use?
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molecular dx arm | Active comparator | Diagnostic Test: Multiplex molecular diagnostic assayPositive blood cultures are tested using a molecular ID system in addition to the standard of care (biochemical identification) |
| Standard of care arm | No intervention | –Positive blood cultures are treated as per normal lab protocol (biochemical identification) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex molecular diagnostic assayTo 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. | Diagnostic test | Molecular dx arm |
Primary outcome
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)
Time frame: 1year
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.
8 secondary outcomes
Time from blood collection to initiation of effective antimicrobial therapy (initiation of antimicrobials active against the identified causative pathogen)
Time frame: 1year
Time from blood collection to pathogen identification
Time frame: 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.
Time frame: 1year
Frequency of discrepant results between molecular identification vs standard of care.
Time frame: 1year
Clinicians' satisfaction with the assay, predominantly in terms of time-to-result and actionable results.
Time frame: 2month
Laboratory professional satisfaction with the assay, predominantly in terms of ease of use and workflow.
Time frame: 2month
In-hospital mortality.
Time frame: 1year
30-day mortality.
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Pernica, MD, FRCPC principal investigator
McMaster University
David Goldfarb, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplex molecular diagnostic assay in people with Bloodstream Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.