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Bacteremia SepsisNANO-RASTNCT05002413

Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis

An observational study of Bacteremia Sepsis, run by Resistell AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device. The results will be compared with current AST gold standard tests to calculate sensitivity, specificity, and accuracy of Resistell Phenotech device. 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 AST
How many people
300 participants
Where
1 siteSwitzerland
Study dates
18 Jun 2021to 19 Feb 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 a pathogenic strain who have been hospitalized at CHUV at the time of blood culture inoculation

Inclusion Criteria: The patients meeting all the following criteria can be recruited in the study:

  • patients over the age of 18 years who sign, or their relatives / legal representatives sign the informed consent form;
  • patients with bacteremia considered to be due to a pathogenic strain;
  • patients hospitalized at CHUV at the time of blood culture inoculation;
  • patients whose positive blood cultures were not older than 24 hours at the time of AST start.

Exclusion Criteria The patients meeting any of the following criteria will be excluded from the study:

  • patient is diagnosed with polymicrobial bacteremia;
  • samples can be excluded from the study during the processing of samples in case of technical errors e.g. failure with attachment of cells, technical problem with the device or sensor, operator's error, etc.

Note: in the event that the capacity of the Resistell instruments is reached for the day, no more ICFs will be obtained for the day.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Institut de microbiologie CHUV R , Suisse +41 21 314 4056

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: NANO-RAST: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis

Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device. The results will be compared with current AST gold standard tests to calculate sensitivity, specificity, and accuracy of Resistell Phenotech device.

Read the detailed description

NANO-RAST: Nano-motion based Resistell AST to determine the antibiotic susceptibility of bacteria causing bacteremia and sepsis.

Study population: patients admitted at the study site with bacteremia considered to be due to a pathogenic strain (E. coli or K. pneumoniae).

Study design: prospective, observational, single arm study.

Being tested
Resistell AST
Keywords
Bacteremia Sepsis Antibiotic Susceptibility Testing AST Gram-negative, Resistell Phenotech, Nanomotion, Cantilever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistell ASTDiagnostic test

    Also called Resistell Antibiotic Susceptibility Test

    The Resistell AST is intended for rapid antibiotic susceptibility testing of most common clinically relevant Gram-negative bacteria causing bloodstream infections (BSI) (bacteremia). In the scope of this study, the Resistell Phenotech device will be used to test the susceptibility of Gram-negative bacteria, in particular Escherichia coli and Klebsiella pneumoniae to ceftriaxone and ciprofloxacin.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of Resistell AST

    The primary endpoint will be the sensitivity of the device in detecting antibiotic susceptibility in blood samples positive for Gram-negative bacteria.

    Measured: Approximately 30 months

Secondary outcomes (2)

  1. Accuracy and Specificity of Resistell AST

    Accuracy and specificity of the device will be calculated to test the effectiveness of the device.

    Measured: Approximately 30 months

  2. Time to Result (TTR)

    Time to Result (TTR) from the point the blood culture turns positive for Gram-negative bacteria to the point antibiotic susceptibility results are obtained from the Resistell AST device.

    Measured: Approximately 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start18 Jun 2021
  3. Primary completion19 Feb 2024
  4. Study completion19 Feb 2024

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002413
Sponsor's protocol ID
2020-01622
Acronym
NANO-RAST
Status last verified
Apr 2024
First submitted
4 Aug 2021
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caruana G, Kritikos A, Vocat A, Tagini F, Delfino A, Luraschi A, Delarze E, Marta PV, Delaloye J, Jacot D, Winnicki J, Orlando C, Sturm A, Jozwiak G, Cichocka D, Greub G. Nanomotion-based technology for rapid antibiotic susceptibility testing among adult patients admitted to a tertiary-care hospital with Gram-negative bacteraemia: a prospective, single arm, comparative diagnostic accuracy study. Clin Microbiol Infect. 2026 Feb;32(2):299-305. doi: 10.1016/j.cmi.2025.10.016. Epub 2025 Oct 29.

    PubMed 41173335

  • Caruana G, Kritikos A, Vocat A, Luraschi A, Delarze E, Sturm A, Pla Verge M, Jozwiak G, Kushwaha S, Delaloye J, Cichocka D, Greub G. Investigating nanomotion-based technology (Resistell AST) for rapid antibiotic susceptibility testing among adult patients admitted to a tertiary-care hospital with Gram-negative bacteraemia: protocol for a prospective, observational, cross-sectional, single-arm study. BMJ Open. 2022 Nov 21;12(11):e064016. doi: 10.1136/bmjopen-2022-064016.

    PubMed 36410804

Questions about this trial

What is this clinical trial studying?

An observational study of Bacteremia Sepsis, run by Resistell AG 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?

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 Apr 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?

Sensitivity of Resistell AST (time frame: Approximately 30 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 NCT05002413, which also lists 2 linked publications.

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 Apr 2024.

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