Osteomyelitis; VertebraNCT05644990
T2MR PCR Detection of ESKAPE Pathogens in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis
An observational study of Osteomyelitis; Vertebra and Endocarditis, Bacterial, run by Charles University, Czech Republic at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis; Vertebra, Endocarditis, Bacterial
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Spine infection or/and endocarditis not confirmed
- Antibiotic treatment longer than 24 hours
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Bulovka
Prague, 180 81
Lucie Cíchová, MD, +420728781647, lucie.cichova@bulovka.cz
Olga Džupová, MD, +420266082705, olga.dzupova@lf3.cuni.cz
About this study
Official title: Direct Detection of ESKAPE Pathogens From Whole Blood Using T2MR Bacteria Panel in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis
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
- Medical subject headings
- Osteomyelitis, Endocarditis, Bacterial, Discitis, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2Bacteria Panel positive | Patients with spondylodiscitis and endocarditis who had positive T2Bacteria Panel test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 4 years
Secondary outcomes (1)
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).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis; VertebraStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Bulovka Hospital, University Hospital, Motol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644990
- Sponsor's protocol ID
- 22-IGS06-36
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Detection of ESKAPE Pathogens From Whole Blood Using T2MR Bacteria Panel in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis
- ClinicalTrials.gov ID
- NCT05644990
- Acronym / sponsor ID
- 22-IGS06-36
- Conditions
- Osteomyelitis; Vertebra, Endocarditis, Bacterial
- Keywords
- Spondylodiscitis, Endocarditis, PCR, T2Bacteria Panel, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Bulovka Hospital, University Hospital, Motol
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2Bacteria Panel positive | – | –Patients with spondylodiscitis and endocarditis who had positive T2Bacteria Panel test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Spine infection or/and endocarditis not confirmed
- Antibiotic treatment longer than 24 hours
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity of the T2 Bacteria Panel
Time frame: 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
Time frame: 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.
1 secondary outcome
Diagnostic utility of T2 Bacteria Panel in other localized infections
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis; Vertebra and Endocarditis, Bacterial, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie Cíchová, MD (+420728781647, lucie.cichova@protonmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the T2 Bacteria Panel (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.