T2MR PCR Detection of ESKAPE Pathogens in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis

Direct Detection of ESKAPE Pathogens From Whole Blood Using T2MR Bacteria Panel in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis

Our prospective observational study focuses on the rapid detection of etiologic agents of pyogenic spondylodiscitis and infective endocarditis using the T2 Bacteria Panel (T2Biosystems). This diagnostic method combines polymerase chain reaction (PCR) and T2 magnetic resonance for detection of bacterial DNA from whole blood samples. It detects six pathogens known by the acronym ESKAPE (E. coli, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. faecium). In recent years, similar studies using the Bacteria Panel and Candida Panel have been performed in patients with bloodstream infections, leaving us with optimistic results.The aim of this study is to verify whether T2B can identify the etiologic agents of localized infections, specifically spondylodiscitis and endocarditis, with better sensitivity and specificity and shorter time to result compared to conventional diagnostics from blood culture. Rapid detection of pathogen may reduce time to targeted pathogen-specific antibiotic therapy and subsequently improve outcomes, shorten the treatment and contribute to slowing the development of antibiotic resistance.

Study Overview

• Status: Recruiting
• Conditions: Endocarditis, Bacterial; Osteomyelitis; Vertebra

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Lucie Cíchová, MD; Phone Number: +420728781647; Email: lucie.cichova@protonmail.com

Study Locations

• Czechia
  • Prague, Czechia, 180 81
    • Recruiting
    • University Hospital Bulovka
    • Contact: Lucie Cíchová, MD; Phone Number: +420728781647; Email: lucie.cichova@bulovka.cz
    • Contact: Olga Džupová, MD; Phone Number: +420266082705; Email: olga.dzupova@lf3.cuni.cz
    • Principal Investigator: Olga Džupová, MD, PhD.
    • Sub-Investigator: Lucie Cíchová, MD
    • Sub-Investigator: Kristýna Herrmannová, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with pyogenic spine infections and/or infective endocarditis, treated at the standard care wards and ICU of the Department of infectious diseases and Department of orthopaedics of the University Hospital Bulovka.

Description

Inclusion Criteria:

• Diagnosis of spondylodiscitis or/and facet joint infection or/and sacroileitis
• Diagnosis of infective endocarditis
• Antibiotic treatment not received or not longer than 24 hours
• Ability to give informed consent

Exclusion Criteria:

• Spine infection or/and endocarditis not confirmed
• Antibiotic treatment longer than 24 hours
• Inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
T2Bacteria Panel positive; Patients with spondylodiscitis and endocarditis who had positive T2Bacteria Panel test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of the T2 Bacteria Panel	Sensitivity and specificity of the T2 Bacteria Panel for ESKAPE pathogens direct detection in patients investigated for suspected pyogenic vertebral infection and/or infective endocarditis, compared with conventional blood culture and/or other relevant biological samples culture .	3 years
Expected treatment outcomes in patients diagnosed by T2 Bacteria Panel	T2 Bacteria Panel is expected to shorten the time to result compared to conventional methods. Rapid detection of the bacteria followed by early pathogen-specific antibiotic therapy should improve the outcomes of patients with spondylodiscitis and infective endocarditis, e.g. mortality, morbidity and length of treatment.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic utility of T2 Bacteria Panel in other localized infections	Patients with other localized infections (other than spine or endocardium infections) who were tested with T2 Bacteria Panel before their diagnosis was assessed, will be excluded from the study. They will be separately evaluated to find out if T2MR diagnostics is useful also in other localised infections (besides of spine infection and endocarditis).	4 years

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: University Hospital, Motol; Bulovka Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: MRI; PCR; Endocarditis; Spondylodiscitis; T2Bacteria Panel
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Spinal Diseases; Bone Diseases; Spondylitis; Cardiovascular Infections; Bone Diseases, Infectious; Endocarditis, Bacterial; Endocarditis; Osteomyelitis; Discitis
• Other Study ID Numbers: 22-IGS06-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No