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

NCT05644990 | Unknown

• 1 other identifier: 22-IGS06-36
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteomyelitis; Vertebra; Endocarditis, Bacterial

Keywords

Spondylodiscitis; Endocarditis; PCR; T2Bacteria Panel; MRI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Diagnostic utility of T2 Bacteria Panel in other localized infections

  4 years

Study Arms (1)

T2Bacteria Panel positive

Patients with spondylodiscitis and endocarditis who had positive T2Bacteria Panel test.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Bulovka Hospital: collaborator
• University Hospital, Motol: collaborator

Study Sites (1)

University Hospital Bulovka

Prague, 180 81, Czechia

RECRUITING

Biospecimen

Retention: NONE RETAINED

4 ml whole blood sample drawn into the K2EDTA vacutainer (BD367861/BD367862/BD368861)

MeSH Terms

Conditions

Osteomyelitis; Endocarditis, Bacterial; Discitis; Endocarditis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Cardiovascular Diseases; Heart Diseases; Spondylitis; Spinal Diseases

Central Study Contacts

Lucie Cíchová, MD

CONTACT

+420728781647; lucie.cichova@protonmail.com

Study Design

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

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)