AMR-DetecTool for the Diagnostic of MDR Bacterial Infections (AMR DetecTool)

February 3, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Inappropriate use of antibiotics
  2. Too late isolation of the carriers
  3. Lack of institutional / hospital level strategies to fight antimicrobial resistance (AMR)
  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94275
        • Bicetre Hospital
  • Hungary
      • Budapest, Hungary, 1428 P .O. box 2
        • Semmelweis University
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic School of Medicine, University of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Cost-consequence analyses for the use of AMR LFIA over standard techniques based on time to results, cost, patient management and outcome analyses.
For the entire study period through study completion, an average of 28 days, without censoring at 28 days if an admission is still ongoing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Commissariat A L'energie Atomique
EIT Health
NG Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP200100
  • 2021-A02176-35 (OTHER: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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