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

Endocarditis, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644990
• Other study ID #: 22-IGS06-36
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2022
• Source: Charles University, Czech Republic
• Contact: Lucie Cíchová, MD
• Phone: +420728781647
• Email: lucie.cichova[@]protonmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Discitis
• Endocarditis
• Endocarditis, Bacterial
• Osteomyelitis

Locations

Country	Name	City	State
Czechia	University Hospital Bulovka	Prague

Sponsors (3)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Bulovka Hospital, University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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