Bacterial Sensitivity TestsAMR DetecToolNCT05378217
AMR-DetecTool for the Diagnostic of MDR Bacterial Infections
An observational study of Bacterial Sensitivity Tests and Antimicrobial Drug Resistance, run by Assistance Publique - Hôpitaux de Paris at 3 sites in 3 countries.
Trial summary
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. The failure to stop the spread of antimicrobial resistance (AMR) is due to a lack of fast detection methods and proper strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Sensitivity Tests, Antimicrobial Drug Resistance
- What is being tested?
- AMR LFIA Assay
- How many people
- 167 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Jul 2022to 12 Jan 2023
- 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: Adult patient with positive bacterial detection and hospitalized in one of the following wards: * Medical ICU * Surgical ICU * Infectious disease unit * Nephrology unit * Urology unit
Who may be able to join
- Patient ≥ 18 years-old
- Informed patient and non-opposition received
- Patients matching with at least one of the following situations:
- With a positive blood culture by Gram-staining. Germ must be identified as a Gram-negative bacteria or a Gram-positive cocci in chain (with a special focus on known Vancomycin-Resistant Enterococci (VRE) carrier)
- With an urinary tract infection >104 leukocytes and positive for bacteria (Gram stain or cytometry)
- High-risk (HR) patient for carbapenemase-producing Enterobacterales (CPE) carriage (repatriated patients, tourist returning from endemic country, patients coming from an endemic hospital (same country), contact patient, former carrier, and local HR patients (Long-Term Care Facility (LTCF), etc…)) who have been sampled a rectal swab for routine testing
- With a bronchoalveolar lavage (BAL) or tracheal aspirate (TA) sample and diagnosed as carrier of any of the targeted resistance genes (10-35% chance to develop a Ventilator-associated pneumonia (VAP) with the MDR bacteria)
Who cannot join
- Patient participation refusal
- Patient subject to judicial protection measure, under tutorship or curatorship
- Patient not-speaking the language spoken in the country of inclusion and without accompanying translator
- Any different sample from the above 4 mentioned one Pregnant women are not excluded to this non-interventional study, as the study does not result in any change in the standard care received by the participant.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Spain1 site
Hospital Clínic School of Medicine, University of Barcelona
Barcelona, 08036
About this study
Official title: Clinical Evaluation of the Accuracy of AMR-DetecTool for the Diagnostic of Infections With Multi Drug Resistant (MDR) Bacteria
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. The failure to stop the spread of antimicrobial resistance (AMR) is due to a lack of fast detection methods and proper strategies.
Novel, rapid and reliable detection and characterization tests are an urgent need for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner.
Read more
AMR-DetecTool or NG Detectool is a detection system for the direct detection of AMR in clinical samples. The clinical sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown.
It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes.
Read the detailed description
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. Among these, the increasing rate of infections caused by Enterobacteriaceae that produce broad-spectrum β-lactamases (ESBLs) and carbapenemases is a major concern worldwide. Moreover, vancomycin-resistance among Enterococcus faecium isolates is becoming a cause of concern in European countries regardless of the geographical location. This increase is due to several factors:
- Inappropriate use of antibiotics
- Too late isolation of the carriers
- Lack of institutional / hospital level strategies to fight antimicrobial resistance (AMR)
- High transfer abilities due to plasmid-encoded resistance genes The failure to stop the spread of AMR is due to a lack of fast detection methods and proper strategies. Rapid detection and rapid characterization tests are an urgent need. European One Health Action Plan against AMR (2017) states that novel, rapid and reliable diagnostics are crucial for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner.
AMR-DetecTool or NG Detectool is a detection system for the direct detection of β-lactamases and carbapenemases in clinical samples. It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes. When a clinical sample with infection suspicion is received at the microbiology laboratory, the techniques used to determine which the appropriate antibiotic is needed require the sample to be cultured for 16h-24h. Thanks to the DetecTool the culturing step is avoided as the sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown.
will be performed in parallel to routine testing on appropriate material of selected samples. No additional samples need to be requested to the participants.
- Being tested
- AMR LFIA Assay
- Keywords
- beta-Lactamase Resistance, Carbapenem-Resistant Enterobacteriaceae, Vancomycin Resistance, Immunoassay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMR LFIA AssayDiagnostic test
AMR LFIA will be performed in parallel to routine testing on appropriate sample types retrieved from routine testing : Blood, urine, BronchoAlveolar Lavage (BAL), Tracheal Aspirate (TA), Rectal swab
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the diagnostic accuracy of the NG DetecTool device in two populations: population 1 (CTX-M-multi, Carba 5), population 2 (Van A / B, Acinetobacter baumannii-specific oxacillinases (OXA- Ab)).
Accuracy indices will be for each whole test and for each enzyme: sensibility, specificity, positive and negative predictive values. The reference will be standard technics used in routine (usual cultures and antibiograms). The list of patients with discrepancies between the two tests will be edited for the laboratory to determine the resistance mechanisms of these strains, using polymerase chain reaction (PCR)and/or whole genome sequencing of the bacteria.
Measured: AMR Detectool results will be obtained within 30 minutes after the patient is included in the study, and the results will be compared to those of the standard routine techniques, that usually require 48 hours.
Secondary outcomes (1)
Describe a diagnostic algorithm for the use of AMR-lateral flow immunoassay (LFIA), allowing thus a more efficient cost-saving patient-pathway structure in hospitals.
Cost-consequence analyses for the use of AMR LFIA over standard techniques based on time to results, cost, patient management and outcome analyses.
Measured: For the entire study period through study completion, an average of 28 days, without censoring at 28 days if an admission is still ongoing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start18 Jul 2022
- Primary completion20 Dec 2022
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Sensitivity TestsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- EIT Health, NG Biotech, Commissariat A L'energie Atomique
- Responsible party
- Sponsor
- Investigators
- Thierry NAAS, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378217
- Sponsor's protocol ID
- APHP200100
- Other IDs
- 2021-A02176-35
- Acronym
- AMR DetecTool
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Accuracy of AMR-DetecTool for the Diagnostic of Infections With Multi Drug Resistant (MDR) Bacteria
- ClinicalTrials.gov ID
- NCT05378217
- Acronym / sponsor ID
- AMR DetecTool / APHP200100
- Keywords
- beta-Lactamase Resistance, Carbapenem-Resistant Enterobacteriaceae, Vancomycin Resistance, Immunoassay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- EIT Health, NG Biotech, Commissariat A L'energie Atomique
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 18 May 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 fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. The failure to stop the spread of antimicrobial resistance (AMR) is due to a lack of fast detection methods and proper strategies.
Novel, rapid and reliable detection and characterization tests are an urgent need for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner.
AMR-DetecTool or NG Detectool is a detection system for the direct detection of AMR in clinical samples. The clinical sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown.
It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes.
Detailed description
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. Among these, the increasing rate of infections caused by Enterobacteriaceae that produce broad-spectrum β-lactamases (ESBLs) and carbapenemases is a major concern worldwide. Moreover, vancomycin-resistance among Enterococcus faecium isolates is becoming a cause of concern in European countries regardless of the geographical location. This increase is due to several factors:
- Inappropriate use of antibiotics
- Too late isolation of the carriers
- Lack of institutional / hospital level strategies to fight antimicrobial resistance (AMR)
- High transfer abilities due to plasmid-encoded resistance genes The failure to stop the spread of AMR is due to a lack of fast detection methods and proper strategies. Rapid detection and rapid characterization tests are an urgent need. European One Health Action Plan against AMR (2017) states that novel, rapid and reliable diagnostics are crucial for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner.
AMR-DetecTool or NG Detectool is a detection system for the direct detection of β-lactamases and carbapenemases in clinical samples. It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes. When a clinical sample with infection suspicion is received at the microbiology laboratory, the techniques used to determine which the appropriate antibiotic is needed require the sample to be cultured for 16h-24h. Thanks to the DetecTool the culturing step is avoided as the sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown.
will be performed in parallel to routine testing on appropriate material of selected samples. No additional samples need to be requested to the participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with positive bacterial detection and hospitalized in one of the following wards: * Medical ICU * Surgical ICU * Infectious disease unit * Nephrology unit * Urology unit
Key inclusion criteria (7 listed)
- Patient ≥ 18 years-old
- Informed patient and non-opposition received
- Patients matching with at least one of the following situations:
- With a positive blood culture by Gram-staining. Germ must be identified as a Gram-negative bacteria or a Gram-positive cocci in chain (with a special focus on known Vancomycin-Resistant Enterococci (VRE) carrier)
- With an urinary tract infection >104 leukocytes and positive for bacteria (Gram stain or cytometry)
Key exclusion criteria (4 listed)
- Patient participation refusal
- Patient subject to judicial protection measure, under tutorship or curatorship
- Patient not-speaking the language spoken in the country of inclusion and without accompanying translator
- Any different sample from the above 4 mentioned one Pregnant women are not excluded to this non-interventional study, as the study does not result in any change in the standard care received by the participant.
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 |
|---|---|---|
| AMR LFIA AssayAMR LFIA will be performed in parallel to routine testing on appropriate sample types retrieved from routine testing : Blood, urine, BronchoAlveolar Lavage (BAL), Tracheal Aspirate (TA), Rectal swab | Diagnostic test | – |
Primary outcome
Estimate the diagnostic accuracy of the NG DetecTool device in two populations: population 1 (CTX-M-multi, Carba 5), population 2 (Van A / B, Acinetobacter baumannii-specific oxacillinases (OXA- Ab)).
Time frame: AMR Detectool results will be obtained within 30 minutes after the patient is included in the study, and the results will be compared to those of the standard routine techniques, that usually require 48 hours.
Accuracy indices will be for each whole test and for each enzyme: sensibility, specificity, positive and negative predictive values. The reference will be standard technics used in routine (usual cultures and antibiograms). The list of patients with discrepancies between the two tests will be edited for the laboratory to determine the resistance mechanisms of these strains, using polymerase chain reaction (PCR)and/or whole genome sequencing of the bacteria.
1 secondary outcome
Describe a diagnostic algorithm for the use of AMR-lateral flow immunoassay (LFIA), allowing thus a more efficient cost-saving patient-pathway structure in hospitals.
Time frame: For the entire study period through study completion, an average of 28 days, without censoring at 28 days if an admission is still ongoing.
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 6 Feb 2023.
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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.
Thierry NAAS, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
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 Bacterial Sensitivity Tests and Antimicrobial Drug Resistance, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 4 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 6 Feb 2023. 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 France, Hungary, Spain. 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?
Estimate the diagnostic accuracy of the NG DetecTool device in two populations: population 1 (CTX-M-multi, Carba 5), population 2 (Van A / B, Acinetobacter baumannii-specific oxacillinases (OXA- Ab)). (time frame: AMR Detectool results will be obtained within 30 minutes after the patient is included in the study, and the results will be compared to those of the standard routine techniques, that usually require 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2023.