SpondylodiscitisSpAlNCT07164235
Spondylodiscitis: a Retrospective Observational Study.
An observational study of Spondylodiscitis, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord, most often with a bacterial etiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylodiscitis
- What is being tested?
- Patients diagnosed with spondylodiscitis
- How many people
- 137 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jul 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient will be taken from adult male or female population aged ≥ 18 years, who received diagnosis of spondylodiscitis confirmed radiologically and microbiologically and who was admitted to Infectious Diseases Unit between January 1, 2017 and December 31, 2024.
Who may be able to join
- Adult male or female subjects aged ≥ 18 years;
- Diagnosis of spondylodiscitis confirmed radiologically and microbiologically
- Admission to Infectious Diseases Unit between January 1, 2017 and December 31, 2024
- Signed informed consent.
Who cannot join
- Age <18 years
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinical Trial Center SC Infrastruttura Ricerca Formazione Innovazione Dipartimento Attività Integrate Ricerca e Innovazione Azienda Ospedaliero-Universitaria SS Antonio e Biagio e C. Arrigo di Alessandria
Alessandria, Piedmont, 15121
About this study
Official title: Spondylodiscitis: a Retrospective Observational Study of the Alessandria University Hospital's Case Series.
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord, most often with a bacterial etiology. Instrumental diagnosis relies on CT, however, contrast-enhanced MRI is the most sensitive test for confirming the diagnosis, as abnormalities are usually detected earlier than with CT. More recently, nuclear diagnostics using 18-fluorodeoxyglucose (18-FDG) PET has proven very useful both for diagnosis and as a tool for monitoring therapeutic efficacy. Etiological diagnosis relies primarily on blood cultures and, if the former is not possible, diagnostic biopsy. Approximately one-third of patients lack a microbiological isolation, and the inability to implement targeted therapy is a known risk factor for treatment failure.
Therapeutic indications are giving way to shorter courses based on the use of oral medications, even though the epidemiology of the countries from which most of the clinical indications and literature originate is profoundly different from that of Italy. An epidemiological analysis of the cases referred to our Center is therefore of primary importance.
Read the detailed description
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord. The etiology is most often bacterial, with the main pathogens implicated being Staphylococcus aureus, streptococci, enterobacteriaceae, and other Gram-negative bacilli. Instrumental diagnosis relies on CT, which allows for the detection of lesions such as bony sequestrations and soft tissue abscesses, as well as the exclusion of epidural abscesses. Contrast-enhanced MRI, however, is the most sensitive test for confirming the diagnosis, as abnormalities are usually detected earlier than with CT.
More recently, nuclear imaging, particularly 18-fluorodeoxyglucose (18-FDG) PET, has proven very useful both for diagnosing tissue with high glucose metabolism and as a tool for monitoring therapeutic efficacy. 18F-FDG-PET/CT has been associated with greater accuracy than MRI in diagnosing early spondylodiscitis in the first 2 weeks after symptom onset. Another important advantage of 18F-FDG-PET/CT over MRI is the potential identification of metastatic infectious foci, especially in patients with bacteremia, allowing for rapid source control. 18F-FDG-PET/CT is also useful for spondylodiscitis caused by mycobacteria, fungi, or Brucella, with some data suggesting different uptake values depending on the etiology.
Etiological diagnosis, however, relies primarily on blood cultures, which can be positive in up to 50% of cases of native spondylodiscitis caused by S. aureus. When noninvasive isolation is not possible, a diagnostic biopsy is necessary. Despite the use of invasive techniques, approximately one-third of patients lack microbiological isolation, and the inability to implement targeted therapy is a known risk factor for treatment failure. It also leads to the use of broad-spectrum antimicrobials, with environmental and sometimes economic consequences.
Therapeutic indications, until now based on case series and cohort studies dating back more than 40 years, are giving way to shorter courses based on the use of orally administered drugs. However, the epidemiology of the countries from which most of the clinical indications and literature on bone infections originate is profoundly different from that of Italy. Therefore, an epidemiological analysis of the cases referred to our Center is of primary importance.
- Conditions
- Spondylodiscitis
- Being tested
- Patients diagnosed with spondylodiscitis
- Keywords
- Spondylodiscitis, infectious processes, 18-FDG, 18 F-FDG-PET/CT
- Medical subject headings
- Discitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients diagnosed with spondylodiscitisOther
Patients admitted to the Infectious Diseases Department of the University Hospital of Alessandria between January 1, 2017, and December 31, 2024, who were diagnosed with spondylodiscitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis
Description of the characteristics of patients diagnosed with spondylodiscitis admitted to the University Hospital of Alessandria from 2017 to 2024
Measured: Baseline
Secondary outcomes (3)
Pre- and post-pandemic comparison of clinical and management characteristics of patients with spondylodiscitis
Comparison of the differences in the characteristics of patients hospitalized before and after 06/03/2020 (pre-pandemic and post-pandemic period)
Measured: Baseline
Comparison of the differences between patients with confirmed and unconfirmed microbiological diagnosis
Evaluate any differences in duration between patients with a confirmed and unconfirmed microbiological diagnosis of spondylodiscitis
Measured: Baseline
Concordance between PET results and antibiotic therapy
Evaluate the concordance between PET results and antibiotic therapy discontinuation in the absence of relapse at 6 months
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start5 Jul 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylodiscitisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164235
- Sponsor's protocol ID
- ASO.MInf.22.04
- Acronym
- SpAl
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spondylodiscitis: a Retrospective Observational Study of the Alessandria University Hospital's Case Series.
- ClinicalTrials.gov ID
- NCT07164235
- Acronym / sponsor ID
- SpAl / ASO.MInf.22.04
- Conditions
- Spondylodiscitis
- Keywords
- Spondylodiscitis, infectious processes, 18-FDG, 18 F-FDG-PET/CT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Sep 2025 (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.
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord, most often with a bacterial etiology. Instrumental diagnosis relies on CT, however, contrast-enhanced MRI is the most sensitive test for confirming the diagnosis, as abnormalities are usually detected earlier than with CT. More recently, nuclear diagnostics using 18-fluorodeoxyglucose (18-FDG) PET has proven very useful both for diagnosis and as a tool for monitoring therapeutic efficacy. Etiological diagnosis relies primarily on blood cultures and, if the former is not possible, diagnostic biopsy. Approximately one-third of patients lack a microbiological isolation, and the inability to implement targeted therapy is a known risk factor for treatment failure.
Therapeutic indications are giving way to shorter courses based on the use of oral medications, even though the epidemiology of the countries from which most of the clinical indications and literature originate is profoundly different from that of Italy. An epidemiological analysis of the cases referred to our Center is therefore of primary importance.
Detailed description
Spondylodiscitis is an infectious process affecting the vertebral bodies, intervertebral discs, and paraspinal tissues, sometimes involving the spinal cord. The etiology is most often bacterial, with the main pathogens implicated being Staphylococcus aureus, streptococci, enterobacteriaceae, and other Gram-negative bacilli. Instrumental diagnosis relies on CT, which allows for the detection of lesions such as bony sequestrations and soft tissue abscesses, as well as the exclusion of epidural abscesses. Contrast-enhanced MRI, however, is the most sensitive test for confirming the diagnosis, as abnormalities are usually detected earlier than with CT.
More recently, nuclear imaging, particularly 18-fluorodeoxyglucose (18-FDG) PET, has proven very useful both for diagnosing tissue with high glucose metabolism and as a tool for monitoring therapeutic efficacy. 18F-FDG-PET/CT has been associated with greater accuracy than MRI in diagnosing early spondylodiscitis in the first 2 weeks after symptom onset. Another important advantage of 18F-FDG-PET/CT over MRI is the potential identification of metastatic infectious foci, especially in patients with bacteremia, allowing for rapid source control. 18F-FDG-PET/CT is also useful for spondylodiscitis caused by mycobacteria, fungi, or Brucella, with some data suggesting different uptake values depending on the etiology.
Etiological diagnosis, however, relies primarily on blood cultures, which can be positive in up to 50% of cases of native spondylodiscitis caused by S. aureus. When noninvasive isolation is not possible, a diagnostic biopsy is necessary. Despite the use of invasive techniques, approximately one-third of patients lack microbiological isolation, and the inability to implement targeted therapy is a known risk factor for treatment failure. It also leads to the use of broad-spectrum antimicrobials, with environmental and sometimes economic consequences.
Therapeutic indications, until now based on case series and cohort studies dating back more than 40 years, are giving way to shorter courses based on the use of orally administered drugs. However, the epidemiology of the countries from which most of the clinical indications and literature on bone infections originate is profoundly different from that of Italy. Therefore, an epidemiological analysis of the cases referred to our Center is of primary importance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient will be taken from adult male or female population aged ≥ 18 years, who received diagnosis of spondylodiscitis confirmed radiologically and microbiologically and who was admitted to Infectious Diseases Unit between January 1, 2017 and December 31, 2024.
Key inclusion criteria (4 listed)
- Adult male or female subjects aged ≥ 18 years;
- Diagnosis of spondylodiscitis confirmed radiologically and microbiologically
- Admission to Infectious Diseases Unit between January 1, 2017 and December 31, 2024
- Signed informed consent.
Key exclusion criteria (2 listed)
- Age <18 years
- Lack of signed 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients diagnosed with spondylodiscitisPatients admitted to the Infectious Diseases Department of the University Hospital of Alessandria between January 1, 2017, and December 31, 2024, who were diagnosed with spondylodiscitis | Other | – |
Primary outcome
Descriptive analysis
Time frame: Baseline
Description of the characteristics of patients diagnosed with spondylodiscitis admitted to the University Hospital of Alessandria from 2017 to 2024
3 secondary outcomes
Pre- and post-pandemic comparison of clinical and management characteristics of patients with spondylodiscitis
Time frame: Baseline
Comparison of the differences between patients with confirmed and unconfirmed microbiological diagnosis
Time frame: Baseline
Concordance between PET results and antibiotic therapy
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Spondylodiscitis, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis (time frame: Baseline). 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 10 Sep 2025.