Resistance BacterialARES_NGSNCT06322173
Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods
A study testing NGS Analysis in people with Resistance Bacterial, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resistance Bacterial
- What is being tested?
- NGS Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2022to Dec 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital
- Samples for which the Information and consent to the conservation of biological samples for research purposes has been signed at the Tropica Biobank or
- Samples for which, after all reasonable efforts, it was not possible to obtain the signature of the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness).
Who cannot join
- Absence of data relating to positivity or negativity to the germs of interest
- Absence of stored residual material
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Elena Pomari, +390456013111, elena.pomari@sacrocuore.it
Elena Pomari
About this study
This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.
- Conditions
- Resistance Bacterial
- Being tested
- NGS Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS AnalysisDiagnostic test
An analytical pipeline with NGS technology developed in the GENRES study will be used for the identification of infecting microorganisms and the drug resistance they carry. For this purpose, a sequencing method will be identified and adopted that can obtain gene sequences of approximately 75 bp in length and on the Illumina MiSeq platform. Furthermore, IT software and bioinformatics analyzes with specific quality control parameters (pre- and post-alignment of reads) will be identified and adopted in order to develop an IVD system that includes a complete package of sequencing kits and software.
| Study group | Role | What they receive |
|---|---|---|
| NGS analysis | Other | Residual anonymized samples stored at -80°C at the Tropica Biobank of the DITM and for which diagnostic analysis for germ infection has previously been carried out at the DITM by blood culture and MDR surveillance in routine diagnostic rectal swab will be used. DNA extraction will be carried out on these residual samples (with subsequent quality and quantification analysis of the nucleic acid) for subsequent NGS analyses. Receives: Diagnostic Test: NGS Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microorganism presence (positive/negative)
Microorganism presence identified by NGS technology.
Measured: Baseline
Microorganism identification
Microorganism identification obtained using NGS technology.
Measured: Baseline
Secondary outcomes (1)
Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible)
Results (resistant/susceptible) obtained using NGS technology in the identification of gene mutations that convey resistance to antibiotics.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start28 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance BacterialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322173
- Sponsor's protocol ID
- 2022-13
- Acronym
- ARES_NGS
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods
- ClinicalTrials.gov ID
- NCT06322173
- Acronym / sponsor ID
- ARES_NGS / 2022-13
- Conditions
- Resistance Bacterial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (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.
This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGS analysis | Other | Diagnostic Test: NGS AnalysisResidual anonymized samples stored at -80°C at the Tropica Biobank of the DITM and for which diagnostic analysis for germ infection has previously been carried out at the DITM by blood culture and MDR surveillance in routine diagnostic rectal swab will be used. DNA extraction will be carried out on these residual samples (with subsequent quality and quantification analysis of the nucleic acid) for subsequent NGS analyses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital
- Samples for which the Information and consent to the conservation of biological samples for research purposes has been signed at the Tropica Biobank or
- Samples for which, after all reasonable efforts, it was not possible to obtain the signature of the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness).
Key exclusion criteria (2 listed)
- Absence of data relating to positivity or negativity to the germs of interest
- Absence of stored residual material
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 |
|---|---|---|
| NGS AnalysisAn analytical pipeline with NGS technology developed in the GENRES study will be used for the identification of infecting microorganisms and the drug resistance they carry. For this purpose, a sequencing method will be identified and adopted that can obtain gene sequences of approximately 75 bp in length and on the Illumina MiSeq platform. Furthermore, IT software and bioinformatics analyzes with specific quality control parameters (pre- and post-alignment of reads) will be identified and adopted in order to develop an IVD system that includes a complete package of sequencing kits and software. | Diagnostic test | NGS analysis |
Primary outcome
Microorganism presence (positive/negative)
Time frame: Baseline
Microorganism presence identified by NGS technology.
Microorganism identification
Time frame: Baseline
Microorganism identification obtained using NGS technology.
1 secondary outcome
Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGS Analysis in people with Resistance Bacterial, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microorganism presence (positive/negative) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 20 Mar 2024.