Infective EndocarditisAMetIPNCT06309680
Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients
An observational study of Infective Endocarditis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infective Endocarditis
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2023to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample will be a consecutive group of patients from hospitals in the trial referred to BHC Endocarditis MDT meeting for management of their disease. Approximately 150 cases are referred to the Endocarditis MDT each year and we reject the diagnosis of endocarditis in 17% of patients by the time of discharge (the cases are highly selected by the time they are referred). The study is designed to be practicable and applicable to a real-world group of patients. Thus, we will study all patients who give consent and have possible or definite endocarditis as per the determination of the clinical Endocarditis MDT. In practice, by the time treatment is completed the number left in the possible endocarditis group is very small (<5%) although when the patient is first referred approximately 20% are in that category. As the disease progresses down its course, the correct diagnosis quickly becomes apparent - especially after surgery.
Who may be able to join
- Patients with possible or confirmed IE referred to BHC Endocarditis MDT
- Age >18
- Able and willing to give informed consent
Who cannot join
- Patients whose diagnosis of endocarditis is "rejected" by the MDT. If this occurs after entry to the study samples will be discarded and the patient informed.
- Patients who have been treated with intravenous antibiotics for more than 7 days at the time of study entry.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Bartholomew's Hospital. West Smithfield
London, EC1A 7BE
About this study
Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs.
We are very keen to improve the treatment of this disease and we are measuring the impact of the treatments that we give to patients so that we have a very clear idea of which treatments work best and also which treatments are less successful.
Read more
A key part of the treatment is the accurate determination of the causative organism which allows appropriate targeted antibiotic and antifungal medication to be administered.
Accurate antibiotic regimes require detection of the causative organism and its sensitivities to each antibiotic. Antibiotic choice is then based on effectiveness, toxicity, ease of use and national guidelines. The current best technique for identifying bacteria is blood culture where organisms are identified by growing them from blood samples. However, this takes up to 5 days from sampling, resulting in delays to the correct diagnosis. Until this time, treatment requires the use of generic, more toxic antibiotic regimes.
New techniques are emerging to identify causative organisms from blood. Metagenomics allows the sequencing of bacterial DNA allowing precise identification of the infecting organism.
Read the detailed description
Infective Endocarditis (IE) occurs when bacteria or fungi settle on heart valves and damage the tissues. The disease can be catastrophic and result in death, heart failure, stroke, kidney failure and other complications. Valvular damage requires cardiac surgery in approximately 50% with endocarditis; early antibiotic treatment reduces complications and improves prognosis, reducing the need for surgery. This is dependent on rapid, accurate determination of the causative organism to administer effective and targeted antimicrobial therapy.
The current best technique for identifying bacteria is blood culture - organisms are identified by growing them from blood. However, this typically takes up to 5 days.
In up to 18% of patients, blood culture fails to identify a causative organism - Blood Culture Negative Infective Endocarditis (BCNIE). As a result, patients are treated with broader spectrum antibiotics which have greater toxicity than targeted regimens, resulting in higher complication rates. Alternative technologies to standard blood culture are therefore needed.
Clinical metagenomics (CMg) allows the sequencing of bacterial DNA from blood samples allowing precise, rapid identification of the pathogen. Hitherto, this technology was expensive and limited. New technology is changing the face of CMg and will potentially allow organisms to be rapidly identified at low cost.
Barts Heart Centre (BHC) is one of the largest cardiac centres in the world, managing 150 IE cases annually. Whilst mortality for IE remains high - 17.1% in the recently published EuroENDO study - in hospital mortality at Barts Heart Centre is ~13%.
The Quadram Institute (QI) is a Biotechnology and Biological Sciences Research Council (BBSRC) funded research institute has special expertise in CMg, including two Nature papers.
This study of 200 patients will assess the accuracy of blood CMg and identify the best time to sample along with its cost effectiveness. Patients will be asked for an extra 10 mL of blood which will be sent to QI along with a routinely taken admission blood sample.
In addition if surgery is clinically required, some of the resected heart valve tissue will also be sent for CMg analysis Results from CMg will be compared to blood culture. A control group of patients undergoing valve surgery for non-IE indications will also be recruited.
To assist future commissioning of a clinical CMg service within the NHS, a cost-effectiveness analysis of use of CMg in the endocarditis diagnosis and treatment pathway will be developed.
- Conditions
- Infective Endocarditis
- Keywords
- endocarditis
- Medical subject headings
- Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CMg in blood
The primary objective of this study is to compare the organisms found from metagenomic testing of blood samples with organisms found from blood culture from a prospective series of sequential patients with IE and compared to blood culture, surgically-resected valve tissue culture (where surgery is undertaken) and opinion of a clinical reference group
Measured: 3 years
Secondary outcomes (3)
To evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE
Any organism identified will be graded by an expert panel into one of three categories:
- Blood culture negative, Nanopore CMg negative
- Blood culture negative, CMg positive, Organism unlikely to cause IE
- Blood culture negative, CMg positive, Organism likely to cause endocarditis We will also send tissue samples for nanopore CMg from all patients operated upon. The identification of the same organism from blood and valve tissue (taken on separate occasions) almost certainly indicates that IE was caused by the organism
Measured: 3 years
1. Optimal timing of blood sampling
The optimal timing of blood sampling for nanopore CMg in IE is unknown. Thus, we will examine the first available Ethylenediaminetetraacetic acid (EDTA) stored sample retained in the labs nd compare it to the results of a sample taken especially for the study, probably a few days later.
Measured: 3 years
3. Metagenomic Techniques
We will compare two different metagenomic techniques - 16s blood testing and host suppression on Nanopore platform.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start24 Apr 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, Quadram Institute Bioscience
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309680
- Sponsor's protocol ID
- 280992
- Acronym
- AMetIP
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients
- ClinicalTrials.gov ID
- NCT06309680
- Acronym / sponsor ID
- AMetIP / 280992
- Conditions
- Infective Endocarditis
- Keywords
- endocarditis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, Quadram Institute Bioscience
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 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.
Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs.
We are very keen to improve the treatment of this disease and we are measuring the impact of the treatments that we give to patients so that we have a very clear idea of which treatments work best and also which treatments are less successful.
A key part of the treatment is the accurate determination of the causative organism which allows appropriate targeted antibiotic and antifungal medication to be administered.
Accurate antibiotic regimes require detection of the causative organism and its sensitivities to each antibiotic. Antibiotic choice is then based on effectiveness, toxicity, ease of use and national guidelines. The current best technique for identifying bacteria is blood culture where organisms are identified by growing them from blood samples. However, this takes up to 5 days from sampling, resulting in delays to the correct diagnosis. Until this time, treatment requires the use of generic, more toxic antibiotic regimes.
New techniques are emerging to identify causative organisms from blood. Metagenomics allows the sequencing of bacterial DNA allowing precise identification of the infecting organism.
Detailed description
Infective Endocarditis (IE) occurs when bacteria or fungi settle on heart valves and damage the tissues. The disease can be catastrophic and result in death, heart failure, stroke, kidney failure and other complications. Valvular damage requires cardiac surgery in approximately 50% with endocarditis; early antibiotic treatment reduces complications and improves prognosis, reducing the need for surgery. This is dependent on rapid, accurate determination of the causative organism to administer effective and targeted antimicrobial therapy.
The current best technique for identifying bacteria is blood culture - organisms are identified by growing them from blood. However, this typically takes up to 5 days.
In up to 18% of patients, blood culture fails to identify a causative organism - Blood Culture Negative Infective Endocarditis (BCNIE). As a result, patients are treated with broader spectrum antibiotics which have greater toxicity than targeted regimens, resulting in higher complication rates. Alternative technologies to standard blood culture are therefore needed.
Clinical metagenomics (CMg) allows the sequencing of bacterial DNA from blood samples allowing precise, rapid identification of the pathogen. Hitherto, this technology was expensive and limited. New technology is changing the face of CMg and will potentially allow organisms to be rapidly identified at low cost.
Barts Heart Centre (BHC) is one of the largest cardiac centres in the world, managing 150 IE cases annually. Whilst mortality for IE remains high - 17.1% in the recently published EuroENDO study - in hospital mortality at Barts Heart Centre is ~13%.
The Quadram Institute (QI) is a Biotechnology and Biological Sciences Research Council (BBSRC) funded research institute has special expertise in CMg, including two Nature papers.
This study of 200 patients will assess the accuracy of blood CMg and identify the best time to sample along with its cost effectiveness. Patients will be asked for an extra 10 mL of blood which will be sent to QI along with a routinely taken admission blood sample.
In addition if surgery is clinically required, some of the resected heart valve tissue will also be sent for CMg analysis Results from CMg will be compared to blood culture. A control group of patients undergoing valve surgery for non-IE indications will also be recruited.
To assist future commissioning of a clinical CMg service within the NHS, a cost-effectiveness analysis of use of CMg in the endocarditis diagnosis and treatment pathway will be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will be a consecutive group of patients from hospitals in the trial referred to BHC Endocarditis MDT meeting for management of their disease. Approximately 150 cases are referred to the Endocarditis MDT each year and we reject the diagnosis of endocarditis in 17% of patients by the time of discharge (the cases are highly selected by the time they are referred). The study is designed to be practicable and applicable to a real-world group of patients. Thus, we will study all patients who give consent and have possible or definite endocarditis as per the determination of the clinical Endocarditis MDT. In practice, by the time treatment is completed the number left in the possible endocarditis group is very small (<5%) although when the patient is first referred approximately 20% are in that category. As the disease progresses down its course, the correct diagnosis quickly becomes apparent - especially after surgery.
Key inclusion criteria (3 listed)
- Patients with possible or confirmed IE referred to BHC Endocarditis MDT
- Age >18
- Able and willing to give informed consent
Key exclusion criteria (2 listed)
- Patients whose diagnosis of endocarditis is "rejected" by the MDT. If this occurs after entry to the study samples will be discarded and the patient informed.
- Patients who have been treated with intravenous antibiotics for more than 7 days at the time of study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of CMg in blood
Time frame: 3 years
The primary objective of this study is to compare the organisms found from metagenomic testing of blood samples with organisms found from blood culture from a prospective series of sequential patients with IE and compared to blood culture, surgically-resected valve tissue culture (where surgery is undertaken) and opinion of a clinical reference group
3 secondary outcomes
To evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE
Time frame: 3 years
1. Optimal timing of blood sampling
Time frame: 3 years
3. Metagenomic Techniques
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis, run by Queen Mary University of London at 1 site in United Kingdom.
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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic accuracy of CMg in blood (time frame: 3 years). 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 9 Jan 2026.