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Completed

NCT Number: NCT05002413

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistell AST

Diagnostic 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.

Other names: Resistell Antibiotic Susceptibility Test

Primary outcomes

  1. Sensitivity of Resistell AST

    Time frame: Approximately 30 months

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

Secondary outcomes

  1. Accuracy and Specificity of Resistell AST

    Time frame: Approximately 30 months

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

  2. Time to Result (TTR)

    Time frame: Approximately 30 months

    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.

Sponsors and collaborators

Lead sponsor

Resistell AG

Industry

Collaborators

  • Innosuisse - Swiss Innovation Agency

Registry information

Official study title

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

Acronym: NANO-RAST

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2021
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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