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
Introduction Effective treatment of bloodstream infections (BSIs) is relying on rapid identification of the causing pathogen and its antibiotic susceptibility. Still, most commercially available antibiotic susceptibility testing (AST) methods are based on monitoring bacterial growth, thus impacting...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-11-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/11/e064016.full |
| _version_ | 1811302739834044416 |
|---|---|
| author | Gilbert Greub Antonios Kritikos Giorgia Caruana Anthony Vocat Amanda Luraschi Eric Delarze Alexander Sturm Marta Pla Verge Grzegorz Jozwiak Samidha Kushwaha Julie Delaloye Danuta Cichocka |
| author_facet | Gilbert Greub Antonios Kritikos Giorgia Caruana Anthony Vocat Amanda Luraschi Eric Delarze Alexander Sturm Marta Pla Verge Grzegorz Jozwiak Samidha Kushwaha Julie Delaloye Danuta Cichocka |
| author_sort | Gilbert Greub |
| collection | DOAJ |
| description | Introduction Effective treatment of bloodstream infections (BSIs) is relying on rapid identification of the causing pathogen and its antibiotic susceptibility. Still, most commercially available antibiotic susceptibility testing (AST) methods are based on monitoring bacterial growth, thus impacting the time to results. The Resistell AST is based on a new technology measuring the nanomotion caused by physiologically active bacterial cells and detecting the changes in nanomotion caused by the exposure to a drug.Methods and analysis This is a single-centre, prospective, cross-sectional, single-arm diagnostic accuracy study to determine the agreement of the Resistell AST on Gram-negative bacteria isolated from blood cultures among patients admitted to a tertiary-care hospital with the reference method. Up to 300 patients will be recruited. Starting with a pilot phase, enrolling 10%–20% of the subjects and limited to Escherichia coli BSI tested for ceftriaxone susceptibility, the main phase will follow, extending the study to Klebsiella pneumoniae and ciprofloxacin.Ethics and dissemination This study has received ethical approval from the Swiss Ethics Committees (swissethics, project 2020-01622). All the case report forms and clinical samples will be assigned a study code by the local investigators and stored anonymously at the reference centre (Lausanne University Hospital). The results will be broadly distributed through conference presentations and peer-reviewed publications.Trial registration number ClinicalTrials.gov Registry (NCT05002413). |
| first_indexed | 2024-04-13T07:34:58Z |
| format | Article |
| id | doaj.art-55b6454371cb46d88c041c194a9350dd |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-13T07:34:58Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-55b6454371cb46d88c041c194a9350dd2022-12-22T02:56:13ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-064016Investigating 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 studyGilbert Greub0Antonios Kritikos1Giorgia Caruana2Anthony Vocat3Amanda Luraschi4Eric Delarze5Alexander Sturm6Marta Pla Verge7Grzegorz Jozwiak8Samidha Kushwaha9Julie Delaloye10Danuta Cichocka11Institute of Microbiology, Department of Laboratory Medicine and Pathology, Lausanne University Hospital, Lausanne, SwitzerlandInstitute of Microbiology, Department of Laboratory Medicine and Pathology, Lausanne University Hospital, Lausanne, SwitzerlandInstitute of Microbiology, Department of Laboratory Medicine and Pathology, Lausanne University Hospital, Lausanne, SwitzerlandInstitute of Microbiology, Department of Laboratory Medicine and Pathology, Lausanne University Hospital, Lausanne, SwitzerlandResistell, Muttenz, SwitzerlandResistell, Muttenz, SwitzerlandResistell, Muttenz, SwitzerlandResistell, Muttenz, SwitzerlandResistell, Muttenz, SwitzerlandHemex, Liestal, SwitzerlandHospital of Morges, Morges, SwitzerlandResistell, Muttenz, SwitzerlandIntroduction Effective treatment of bloodstream infections (BSIs) is relying on rapid identification of the causing pathogen and its antibiotic susceptibility. Still, most commercially available antibiotic susceptibility testing (AST) methods are based on monitoring bacterial growth, thus impacting the time to results. The Resistell AST is based on a new technology measuring the nanomotion caused by physiologically active bacterial cells and detecting the changes in nanomotion caused by the exposure to a drug.Methods and analysis This is a single-centre, prospective, cross-sectional, single-arm diagnostic accuracy study to determine the agreement of the Resistell AST on Gram-negative bacteria isolated from blood cultures among patients admitted to a tertiary-care hospital with the reference method. Up to 300 patients will be recruited. Starting with a pilot phase, enrolling 10%–20% of the subjects and limited to Escherichia coli BSI tested for ceftriaxone susceptibility, the main phase will follow, extending the study to Klebsiella pneumoniae and ciprofloxacin.Ethics and dissemination This study has received ethical approval from the Swiss Ethics Committees (swissethics, project 2020-01622). All the case report forms and clinical samples will be assigned a study code by the local investigators and stored anonymously at the reference centre (Lausanne University Hospital). The results will be broadly distributed through conference presentations and peer-reviewed publications.Trial registration number ClinicalTrials.gov Registry (NCT05002413).https://bmjopen.bmj.com/content/12/11/e064016.full |
| spellingShingle | Gilbert Greub Antonios Kritikos Giorgia Caruana Anthony Vocat Amanda Luraschi Eric Delarze Alexander Sturm Marta Pla Verge Grzegorz Jozwiak Samidha Kushwaha Julie Delaloye Danuta Cichocka 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/11/e064016.full |
| work_keys_str_mv | AT gilbertgreub investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT antonioskritikos investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT giorgiacaruana investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT anthonyvocat investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT amandaluraschi investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT ericdelarze investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT alexandersturm investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT martaplaverge investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT grzegorzjozwiak investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT samidhakushwaha investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT juliedelaloye investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy AT danutacichocka investigatingnanomotionbasedtechnologyresistellastforrapidantibioticsusceptibilitytestingamongadultpatientsadmittedtoatertiarycarehospitalwithgramnegativebacteraemiaprotocolforaprospectiveobservationalcrosssectionalsinglearmstudy |