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

Recruiting

• Conditions: Osteomyelitis; Vertebra; Endocarditis, Bacterial

• Registration Number: NCT05644990
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-09
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Primary Completion: 2024-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the T2 Bacteria Panel	3 years	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 .
Expected treatment outcomes in patients diagnosed by T2 Bacteria Panel	4 years	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.

Secondary Outcome Measures

Name	Time	Method
Diagnostic utility of T2 Bacteria Panel in other localized infections	4 years	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).

Trial Locations

Locations (1)

University Hospital Bulovka; 🇨🇿 Prague, Czechia