Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients

NCT06309680 | Active Not Recruiting DMC

• 1 other identifier: 280992
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infective Endocarditis

Keywords

endocarditis

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (3)

• To evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE

  3 years

• 1. Optimal timing of blood sampling

  3 years

• 3. Metagenomic Techniques

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients with possible or confirmed IE referred to BHC Endocarditis MDT
• Age \>18
• Able and willing to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator
• Quadram Institute Bioscience: collaborator

Study Sites (1)

St Bartholomew's Hospital. West Smithfield

London, EC1A 7BE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. EDTA peripheral blood sample 2. Heart Valve tissue sample

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 13, 2024
• Study Start: April 24, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

GB (1)