PneumoniaBIOARTENCT06141395
NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification
An observational study of Pneumonia and Acute Pyelonephritis, run by Hellenic Institute for the Study of Sepsis at 4 sites in Greece.
Trial summary
Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Acute Pyelonephritis, Bacteremia
- What is being tested?
- NGS-based assay for bacterial identification
- How many people
- 100 participants
- Where
- 4 sitesGreece
- Study dates
- 16 Nov 2023to 14 Mar 2024
- 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: Patients who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.
Who may be able to join
- Age equal to or above 18 years.
- Both genders.
- Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
- Patients with high suspicion of infection with at least one sign of the quick SOFA score (i.e. one of mental confusion, more than 22 breaths per minute or systolic blood pressure less than 100mmHg).
Who cannot join
- Age below 18 years.
- Denial for written informed consent.
- Patients already receiving antibiotics.
- Pregnancy or lactation.
Trial locations and contacts
4 sites in 1 country.
Greece4 sites
1st Department of Internal Medicine, General Hospital of Eleusis THRIASIO
Athens
3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA
Athens
4th Department of Internal Medicine,"Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School
Chaïdári, Attica, 12462
3rd Department of Internal Medicine, General Hospital of Nikaia AGIOS PANTELEIMON
Nikaia
About this study
Official title: Development Of A Non-Interventional Diagnostic Ngs-Based Assay Of Blood Samples Of Sepsis Patients For Rapid Bacterial Identification Based On Next Generation Sequencing.
Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.
Read the detailed description
Early start of antimicrobials is the cornerstone of management of critically ill patients. The appropriate time window for this early intervention may vary greatly, but it is considered to be one to 3 hours from hospital admission. However, the choice of the antimicrobials for early intervention relies on empirical selection and may several times be inappropriate due to the emergence of antimicrobial resistance. The only way to overcome this difficulty is guidance through early microbial identification and antibiotic susceptibility testing (AST). However, blood cultures are positive in almost 20% of critically ill patients and AST may delay as much as 72 hours.
This means that another type of approach is warranted which will tackle the major limitation of standard-of-care (SoC) microbiology, namely, the need to incubate whole blood into flasks enriched with growth media which necessitates subculturing once a blood flask turns positive. It is evident that rapid identification of the pathogen followed by AST using whole blood without the need of blood culture can be a major advance in the diagnostic field.
The present study is based on previous analysis of ethylenediaminetetraacetic acid (EDTA) whole blood coming from patients with known bloodstream infection. Next generation sequencing (NGS) of bacterial DNA extracted from whole blood managed to identify the correct pathogen. This study is aiming at the validation of this NGS -based assay in a broader number of patients.
- Conditions
- Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
- Being tested
- NGS-based assay for bacterial identification
- Keywords
- Bacterial Infection, Antimicrobial susceptibility testing, Next generation sequencing, Blood culture, Time to pathogen identification
- Medical subject headings
- Pneumonia, Bacteremia, Cholangitis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS-based assay for bacterial identificationDiagnostic test
A total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an infection | Patients with high suspicion of infection with at least one sign of the quick Sequential Organ Failure Assessment (qSOFA) score Receives: Diagnostic Test: NGS-based assay for bacterial identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of matching between the results of Next Generation Sequencing and the Standard-of-Care culture for patients with sepsis.
This will be done by assessing the sensitivity, the specificity, the positive predictive value and the negative predictive value of Next Generation Sequencing and Standard-of-Care. For the analysis of this diagnostic performance, the results of the SoC cultures will be considered the "gold standard" for comparisons.
Measured: 7 days
Secondary outcomes (2)
Difference in time to identification of the bacterial pathogen between Next Generation Sequencing and the Standard-of-Care culture
The time from start of incubation until final identification will be recorded and compared between the two methods.
Measured: 7 days
Difference in time to Antibiotic Susceptibility Testing between Next Generation Sequencing and the Standard-of-Care culture
The time from start of incubation until the Antibiotic Susceptibility Testing will be recorded and compared between the two methods.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start16 Nov 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Collaborators
- The BioArte
- Responsible party
- Sponsor
- Investigators
- Evangelos Giamarellos-Bourboulis, MD,PhD, Study chair, Hellenic Institute for the Study of Sepsis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141395
- Sponsor's protocol ID
- BIOARTE
- Acronym
- BIOARTE
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of A Non-Interventional Diagnostic Ngs-Based Assay Of Blood Samples Of Sepsis Patients For Rapid Bacterial Identification Based On Next Generation Sequencing.
- ClinicalTrials.gov ID
- NCT06141395
- Acronym / sponsor ID
- BIOARTE / BIOARTE
- Conditions
- Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
- Keywords
- Bacterial Infection, Antimicrobial susceptibility testing, Next generation sequencing, Blood culture, Time to pathogen identification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Collaborators
- The BioArte
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 21 Nov 2023 (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.
Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.
Detailed description
Early start of antimicrobials is the cornerstone of management of critically ill patients. The appropriate time window for this early intervention may vary greatly, but it is considered to be one to 3 hours from hospital admission. However, the choice of the antimicrobials for early intervention relies on empirical selection and may several times be inappropriate due to the emergence of antimicrobial resistance. The only way to overcome this difficulty is guidance through early microbial identification and antibiotic susceptibility testing (AST). However, blood cultures are positive in almost 20% of critically ill patients and AST may delay as much as 72 hours.
This means that another type of approach is warranted which will tackle the major limitation of standard-of-care (SoC) microbiology, namely, the need to incubate whole blood into flasks enriched with growth media which necessitates subculturing once a blood flask turns positive. It is evident that rapid identification of the pathogen followed by AST using whole blood without the need of blood culture can be a major advance in the diagnostic field.
The present study is based on previous analysis of ethylenediaminetetraacetic acid (EDTA) whole blood coming from patients with known bloodstream infection. Next generation sequencing (NGS) of bacterial DNA extracted from whole blood managed to identify the correct pathogen. This study is aiming at the validation of this NGS -based assay in a broader number of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an infection | – | Diagnostic Test: NGS-based assay for bacterial identificationPatients with high suspicion of infection with at least one sign of the quick Sequential Organ Failure Assessment (qSOFA) score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.
Key inclusion criteria (4 listed)
- Age equal to or above 18 years.
- Both genders.
- Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
- Patients with high suspicion of infection with at least one sign of the quick SOFA score (i.e. one of mental confusion, more than 22 breaths per minute or systolic blood pressure less than 100mmHg).
Key exclusion criteria (4 listed)
- Age below 18 years.
- Denial for written informed consent.
- Patients already receiving antibiotics.
- Pregnancy or lactation.
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-based assay for bacterial identificationA total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms. | Diagnostic test | Patients with an infection |
Primary outcome
The rate of matching between the results of Next Generation Sequencing and the Standard-of-Care culture for patients with sepsis.
Time frame: 7 days
This will be done by assessing the sensitivity, the specificity, the positive predictive value and the negative predictive value of Next Generation Sequencing and Standard-of-Care. For the analysis of this diagnostic performance, the results of the SoC cultures will be considered the "gold standard" for comparisons.
2 secondary outcomes
Difference in time to identification of the bacterial pathogen between Next Generation Sequencing and the Standard-of-Care culture
Time frame: 7 days
Difference in time to Antibiotic Susceptibility Testing between Next Generation Sequencing and the Standard-of-Care culture
Time frame: 7 days
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 29 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Evangelos Giamarellos-Bourboulis, MD,PhD study chair
Hellenic Institute for the Study of Sepsis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Acute Pyelonephritis, run by Hellenic Institute for the Study of Sepsis at 4 sites in Greece.
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 4 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 29 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 4 sites in Greece. 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?
The rate of matching between the results of Next Generation Sequencing and the Standard-of-Care culture for patients with sepsis. (time frame: 7 days). 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 29 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.