An observational study in Osteomyelitis; Vertebra and Endocarditis, Bacterial, sponsored by Charles University, Czech Republic. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Charles University, Czech Republic · Observational
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 50 is below the median of 86 across 41 observational studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Charles University, Czech Republic is the lead sponsor of 228 studies on the registry; 76 are open to participants now.
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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.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with spondylodiscitis and endocarditis who had positive T2Bacteria Panel test.
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 .
Time frame: 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.
Time frame: 4 years
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).
Time frame: 4 years
Plan to share: No
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