Bacteremia SepsisPHENOTECH-1NCT05613322
Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia
An observational study of Bacteremia Sepsis, run by Resistell AG at 3 sites in 3 countries.
Trial summary
The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia Sepsis
- What is being tested?
- Resistell Phenotech
- How many people
- 246 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Jan 2023to 5 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bacteremia considered to be due to E. coli or K. pneumoniae.
Who may be able to join
- Patients who have signed a General Consent form approving use of their residual blood samples for research purposes (applicable at CHUV only)
- Patients who have signed a consent allowing the use of their residual sample (Restprobenerklärung) (applicable at MUI, only)
- Patients over the age of 18 years (>18)
- Patients with bacteremia considered to be due to E. coli or K. pneumoniae
- Patients whose positive blood cultures were not older than 24 hours at the time of AST start
Who cannot join
- Patients with documented refusal of the use of biological material for research purposes (applicable at CHUV, only)
- Patients with polymicrobial bacteremia
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Austria1 site
Medizinische Universität Innsbruck (MUI), Institut für Hygiene und Medizinische Mikrobiologie
Innsbruck, Innsbruck, 6020
Spain1 site
Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Madrid, Madrid, 28034
Switzerland1 site
Centre hospitalier universitaire vaudois (CHUV), Institut de Microbiologie
Lausanne, Lausanne, 1011
About this study
Official title: Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia: a Prospective, Non-interventional, Multi-centric, Clinical Performance Study
The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study.
The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.
- Conditions
- Bacteremia Sepsis
- Being tested
- Resistell Phenotech
- Keywords
- Antibiotic, Susceptibility, AST, E.coli, K. pneumoniae, Phenotech
- Medical subject headings
- Disease Susceptibility, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistell PhenotechDiagnostic test
Resistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Resistell Phenotech vs Kirby-Bauer
To assess the sensitivity of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.
Measured: 18 months
Secondary outcomes (4)
Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer
To assess the specificity and accuracy of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.
Measured: 18 months
Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators
To assess the sensitivity, specificity, and accuracy of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to other routine diagnostic AST tests run at each site
Measured: 18 months
Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators
To assess the difference between time to result (TTR) of Resistell Phenotech and the TTR of the Kirby-Bauer and the other routine diagnostic AST methods run at each site.
Measured: 18 months
Category agreement and discrepancies
To assess category agreement (CA), very major discrepancy (VMD), major discrepancy (MD) of the results obtained with Resistell Phenotech compared to the Kirby-Bauer and the other routine diagnostic AST test results at each site
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start18 Jan 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Why it stopped: Statistical power for primary endpoint (sensitivity) for E. coli and K. pneumoniae and ceftriaxone was achieved
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 Bacteremia SepsisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resistell AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613322
- Sponsor's protocol ID
- PHENOTECH-1
- Acronym
- PHENOTECH-1
- Status last verified
- Oct 2024
- First submitted
- 4 Nov 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sturm A, Jozwiak G, Verge MP, Munch L, Cathomen G, Vocat A, Luraschi-Eggemann A, Orlando C, Fromm K, Delarze E, Swiatkowski M, Wielgoszewski G, Totu RM, Garcia-Castillo M, Delfino A, Tagini F, Kasas S, Lass-Florl C, Gstir R, Canton R, Greub G, Cichocka D. Accurate and rapid antibiotic susceptibility testing using a machine learning-assisted nanomotion technology platform. Nat Commun. 2024 Mar 18;15(1):2037. doi: 10.1038/s41467-024-46213-y.
PubMed 38499536
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia: a Prospective, Non-interventional, Multi-centric, Clinical Performance Study
- ClinicalTrials.gov ID
- NCT05613322
- Acronym / sponsor ID
- PHENOTECH-1 / PHENOTECH-1
- Conditions
- Bacteremia Sepsis
- Keywords
- Antibiotic, Susceptibility, AST, E.coli, K. pneumoniae, Phenotech
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Statistical power for primary endpoint (sensitivity) for E. coli and K. pneumoniae and ceftriaxone was achieved
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Resistell AGIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 14 Nov 2022 (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.
The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study.
The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bacteremia considered to be due to E. coli or K. pneumoniae.
Key inclusion criteria (5 listed)
- Patients who have signed a General Consent form approving use of their residual blood samples for research purposes (applicable at CHUV only)
- Patients who have signed a consent allowing the use of their residual sample (Restprobenerklärung) (applicable at MUI, only)
- Patients over the age of 18 years (>18)
- Patients with bacteremia considered to be due to E. coli or K. pneumoniae
- Patients whose positive blood cultures were not older than 24 hours at the time of AST start
Key exclusion criteria (2 listed)
- Patients with documented refusal of the use of biological material for research purposes (applicable at CHUV, only)
- Patients with polymicrobial bacteremia
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 |
|---|---|---|
| Resistell PhenotechResistell Phenotech IVD device used to assess susceptibility of Gram negative bacteria to antibiotics. | Diagnostic test | – |
Primary outcome
Sensitivity of the Resistell Phenotech vs Kirby-Bauer
Time frame: 18 months
To assess the sensitivity of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.
4 secondary outcomes
Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer
Time frame: 18 months
Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators
Time frame: 18 months
Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators
Time frame: 18 months
Category agreement and discrepancies
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Statistical power for primary endpoint (sensitivity) for E. coli and K. pneumoniae and ceftriaxone was achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 38499536Sturm A, Jozwiak G, Verge MP, Munch L, Cathomen G, Vocat A, Luraschi-Eggemann A, Orlando C, Fromm K, Delarze E, Swiatkowski M, Wielgoszewski G, Totu RM, Garcia-Castillo M, Delfino A, Tagini F, Kasas S, Lass-Florl C, Gstir R, Canton R, Greub G, Cichocka D. Accurate and rapid antibiotic susceptibility testing using a machine learning-assisted nanomotion technology platform. Nat Commun. 2024 Mar 18;15(1):2037. doi: 10.1038/s41467-024-46213-y.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia Sepsis, run by Resistell AG at 3 sites in 3 countries.
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 5 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: stopped early, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Spain, 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 was stopped early (reason given: Statistical power for primary endpoint (sensitivity) for E. coli and K. pneumoniae and ceftriaxone was achieved). Results are not available in the source record.
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?
Sensitivity of the Resistell Phenotech vs Kirby-Bauer (time frame: 18 months). 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 NCT05613322, 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 26 Oct 2024.