Bloodstream InfectionsNCT04156633
Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard
An observational study of Bloodstream Infections, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In this before-after study, different new methods for bacterial species identification from positive blood cultures will be compared towards historic controls. All samples are analyzed within the routine workflow for bacterial species identification and antibiotic resistance profiling. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bloodstream Infections
- What is being tested?
- conventional identification method: biochemical profiling or MALDI-TOF MS, new identification method: Biofire FilmArray© BCID panel and new identification method: metagenomic WGS
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2019to 31 Jul 2022
- Phase
- Observational
- 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
Study population: All patients with positive blood cultures hospitalized at the university hospital Basel between August 2016 and October 2019 are included.
Who may be able to join
- patients with positive blood cultures hospitalized between August 2016 and October 2019
- documented refusal of the general consent
Who cannot join
- outpatients
- patients hospitalized in other hospitals
- patients with known bacteremia diagnosed in another hospital
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Clinical Bacteriology & Mycology, University Hospital Basel
Basel, 4031
About this study
In this before-after study, different new methods for bacterial species identification from positive blood cultures will be compared towards historic controls. All samples are analyzed within the routine workflow for bacterial species identification and antibiotic resistance profiling. Patients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls) will be compared to patients from 2018 and 2019 with a new identification method (cases). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or Matrix-assisted Laser-Desorption/Ionization Time-of-Flight (MALDI-TOF MS). The new identification of positive blood cultures methods include (i) either the newly introduced Biofire FilmArray© Blood Culture Identification (BCID) panel or (ii) in a subset of patients whole genome sequencing (WGS) approaches.
- Conditions
- Bloodstream Infections
- Being tested
- conventional identification method: biochemical profiling or MALDI-TOF MS, new identification method: Biofire FilmArray© BCID panel, new identification method: metagenomic WGS
- Keywords
- MALDI-TOF MS, Biofire FilmArray© Blood Culture Identification (BCID) panel, shotgun metagenomic approach
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional identification method: biochemical profiling or MALDI-TOF MSDiagnostic test
Identification of bacteria in positive blood cultures with MALDI-TOF MS from a subculture usually one day after the signal for a positive blood culture appears (from 2016 to 2018)
new identification method: Biofire FilmArray© BCID panelDiagnostic test
The Biofire FilmArray© BCID Panel is performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies (from 2018 and 2019)
new identification method: metagenomic WGSDiagnostic test
shotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene (from 2018 and 2019)
| Study group | Role | What they receive |
|---|---|---|
| conventional identification methods (controls) | Patients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or MALDI-TOF MS. Receives: Diagnostic Test: conventional identification method: biochemical profiling or MALDI-TOF MS | |
| new identification method (cases)Biofire FilmArray© BCID panel | Patients with positive blood cultures from 2018 and 2019 receiving a new identification method (cases). The new identification method is the Biofire FilmArray© Blood Culture Identification (BCID) panel, a polymerase chain reaction-based method, performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies. The assays allow to identify a panel of 20 most commonly Gram-positive and -negative bacteria and yeast causing blood stream infections. It also allows to determine three resistance genes (mecA, vanA/B and KPC). Receives: Diagnostic Test: new identification method: Biofire FilmArray© BCID panel | |
| new identification method (cases) WGS approaches | Patients with positive blood cultures from 2018 and 2019 receiving a new identification method (cases). The new identification of positive blood cultures methods in a subset of patients is a whole genome sequencing approach. This so called shotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene. Receives: Diagnostic Test: new identification method: metagenomic WGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to optimal antibiotic treatment in hours from positive blood cultures (hours)
Time from blood draw for blood culture testing to start of optimal antibiotic treatment (hours)
Measured: 24 hours from collection of blood cultures
Secondary outcomes (4)
Time to effective antibiotic treatment in hours from positive blood cultures (hours)
Time from blood draw for blood culture testing to start of effective antibiotic treatment (hours)
Measured: 24 hours from collection of blood cultures
all-cause in hospital mortality (number)
all-cause in hospital mortality (number)
Measured: from admission to hospital until release from hospital (approximately 30 days)
duration on ICU in days
duration on ICU in days
Measured: from admission to ICU until release from ICU (approximately 20 days)
time to Gram staining and resistance profile from positive blood cultures (hours)
time to Gram staining and resistance profile from positive blood cultures (hours)
Measured: 24 hours from collection of blood cultures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start17 Oct 2019
- Primary completion1 Mar 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bloodstream InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Egli, PD Dr. med, Principal investigator, Division of Clinical Bacteriology & Mycology; University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156633
- Sponsor's protocol ID
- 2019-01860; qu19Egli2
- Other IDs
- 2019
- Status last verified
- May 2024
- First submitted
- 5 Nov 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agnetti J, Buchler AC, Osthoff M, Helfenstein F, Weisser M, Siegemund M, Bassetti S, Bingisser R, Schaefer DJ, Clauss M, Hinic V, Tschudin-Sutter S, Battig V, Khanna N, Egli A. Identification of microorganisms by a rapid PCR panel from positive blood cultures leads to faster optimal antimicrobial therapy - a before-after study. BMC Infect Dis. 2023 Oct 26;23(1):730. doi: 10.1186/s12879-023-08732-9.
PubMed 37884860
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard
- ClinicalTrials.gov ID
- NCT04156633
- Acronym / sponsor ID
- 2019-01860; qu19Egli2
- Conditions
- Bloodstream Infections
- Keywords
- MALDI-TOF MS, Biofire FilmArray© Blood Culture Identification (BCID) panel, shotgun metagenomic approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 7 Nov 2019 (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.
In this before-after study, different new methods for bacterial species identification from positive blood cultures will be compared towards historic controls. All samples are analyzed within the routine workflow for bacterial species identification and antibiotic resistance profiling. Patients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls) will be compared to patients from 2018 and 2019 with a new identification method (cases). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or Matrix-assisted Laser-Desorption/Ionization Time-of-Flight (MALDI-TOF MS). The new identification of positive blood cultures methods include (i) either the newly introduced Biofire FilmArray© Blood Culture Identification (BCID) panel or (ii) in a subset of patients whole genome sequencing (WGS) approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional identification methods (controls) | – | Diagnostic Test: conventional identification method: biochemical profiling or MALDI-TOF MSPatients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or MALDI-TOF MS. |
| new identification method (cases)Biofire FilmArray© BCID panel | – | Diagnostic Test: new identification method: Biofire FilmArray© BCID panelPatients with positive blood cultures from 2018 and 2019 receiving a new identification method (cases). The new identification method is the Biofire FilmArray© Blood Culture Identification (BCID) panel, a polymerase chain reaction-based method, performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies. The assays allow to identify a panel of 20 most commonly Gram-positive and -negative bacteria and yeast causing blood stream infections. It also allows to determine three resistance genes (mecA, vanA/B and KPC). |
| new identification method (cases) WGS approaches | – | Diagnostic Test: new identification method: metagenomic WGSPatients with positive blood cultures from 2018 and 2019 receiving a new identification method (cases). The new identification of positive blood cultures methods in a subset of patients is a whole genome sequencing approach. This so called shotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with positive blood cultures hospitalized at the university hospital Basel between August 2016 and October 2019 are included.
Key inclusion criteria (2 listed)
- patients with positive blood cultures hospitalized between August 2016 and October 2019
- documented refusal of the general consent
Key exclusion criteria (3 listed)
- outpatients
- patients hospitalized in other hospitals
- patients with known bacteremia diagnosed in another hospital
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 |
|---|---|---|
| conventional identification method: biochemical profiling or MALDI-TOF MSIdentification of bacteria in positive blood cultures with MALDI-TOF MS from a subculture usually one day after the signal for a positive blood culture appears (from 2016 to 2018) | Diagnostic test | conventional identification methods (controls) |
| new identification method: Biofire FilmArray© BCID panelThe Biofire FilmArray© BCID Panel is performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies (from 2018 and 2019) | Diagnostic test | new identification method (cases)Biofire FilmArray© BCID panel |
| new identification method: metagenomic WGSshotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene (from 2018 and 2019) | Diagnostic test | new identification method (cases) WGS approaches |
Primary outcome
Time to optimal antibiotic treatment in hours from positive blood cultures (hours)
Time frame: 24 hours from collection of blood cultures
Time from blood draw for blood culture testing to start of optimal antibiotic treatment (hours)
4 secondary outcomes
Time to effective antibiotic treatment in hours from positive blood cultures (hours)
Time frame: 24 hours from collection of blood cultures
all-cause in hospital mortality (number)
Time frame: from admission to hospital until release from hospital (approximately 30 days)
duration on ICU in days
Time frame: from admission to ICU until release from ICU (approximately 20 days)
time to Gram staining and resistance profile from positive blood cultures (hours)
Time frame: 24 hours from collection of blood cultures
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 9 May 2024.
- Results publication: PubMed 37884860Agnetti J, Buchler AC, Osthoff M, Helfenstein F, Weisser M, Siegemund M, Bassetti S, Bingisser R, Schaefer DJ, Clauss M, Hinic V, Tschudin-Sutter S, Battig V, Khanna N, Egli A. Identification of microorganisms by a rapid PCR panel from positive blood cultures leads to faster optimal antimicrobial therapy - a before-after study. BMC Infect Dis. 2023 Oct 26;23(1):730. doi: 10.1186/s12879-023-08732-9.
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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.
Adrian Egli, PD Dr. med principal investigator
Division of Clinical Bacteriology & Mycology; University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infections, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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 9 May 2024. 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 Switzerland. 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 to optimal antibiotic treatment in hours from positive blood cultures (hours) (time frame: 24 hours from collection of blood cultures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04156633, which also lists 1 linked publication.
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 9 May 2024.