Spondylodiscitis: a Retrospective Observational Study.

NCT07164235 | Active Not Recruiting

• 1 other identifier: ASO.MInf.22.04
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spondylodiscitis

Keywords

Spondylodiscitis; infectious processes; 18-FDG; 18 F-FDG-PET/CT

Outcome Measures

Primary Outcomes (1)

• Descriptive analysis

  Description of the characteristics of patients diagnosed with spondylodiscitis admitted to the University Hospital of Alessandria from 2017 to 2024

  Baseline

Secondary Outcomes (3)

• Pre- and post-pandemic comparison of clinical and management characteristics of patients with spondylodiscitis

  Baseline

• Comparison of the differences between patients with confirmed and unconfirmed microbiological diagnosis

  Baseline

• Concordance between PET results and antibiotic therapy

  Baseline

Interventions

Patients diagnosed with spondylodiscitis OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years
• Lack of signed informed consent

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

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, Italy

Location

MeSH Terms

Conditions

Discitis

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: July 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

IT (1)