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

NCT ID: NCT05644990

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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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

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Conditions

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Osteomyelitis; Vertebra Endocarditis, Bacterial

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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T2Bacteria Panel positive

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bulovka Hospital

OTHER

Sponsor Role collaborator

University Hospital, Motol

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Bulovka

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Lucie Cíchová, MD

Role: CONTACT

+420728781647

Facility Contacts

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Lucie Cíchová, MD

Role: primary

+420728781647

Olga Džupová, MD

Role: backup

+420266082705

Other Identifiers

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22-IGS06-36

Identifier Type: -

Identifier Source: org_study_id

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