SpondylodiscitisNCT05806905
Spondylodiscitis Cases at Assiut University Hospital
An observational study of Spondylodiscitis, run by Assiut University at 1 site in Egypt.
Trial summary
The term Spondylodiscitis (SD) involves infection of the vertebra (Spondylitis), infection of the intervertebral disc (Discitis), or both (Spondylodiscitis) Spondylodiscitis is a rare disease accounting for 2.7% of all cases of pyogenic osteomyelitis, with incidence varying from 1 per 100,000/year to 1 per… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spondylodiscitis
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to Sep 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms and radiological findings suggestive of spondylodiscitis
Who may be able to join
- All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms suggestive of spondylodiscitis in all age groups including patients with known medical conditions and patients who underwent previous spine surgeries (post operative spondylodiscitis)
Who cannot join
- No patients will be excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Ahmed Osama, Resident, 01064755625, Ahmed.20133774@med.aun.edu.eg
About this study
Official title: Epidemiology, Clinical Features and Diagnosis of Spondylodiscitis at Assiut University Hospital
The term Spondylodiscitis (SD) involves infection of the vertebra (Spondylitis), infection of the intervertebral disc (Discitis), or both (Spondylodiscitis) Spondylodiscitis is a rare disease accounting for 2.7% of all cases of pyogenic osteomyelitis, with incidence varying from 1 per 100,000/year to 1 per 250,000/year However, there is evidence that the incidence is rising due to longer life expectancy for patients with increasing incidence of chronic debilitating disease including diabetes mellitus, malignancies ,(Human Immunodeficiency Virus (HIV)/ Acquired Immunodeficiency Syndrome (AIDs) , immunosuppressive therapy, increasing numbers of Intravenous drug users , and spinal surgeries.
Pathogens can reach the spine either by: hematogenous spread, direct external inoculation, or spread from contiguous tissues harboring these pathogens. The hematogenous route is the predominant one, allowing seeding of infection from distant sites into the vertebral column.
Since spondylodiscitis has not been studied in a clinical trial at our hospital, and information about this disease has come from retrospective case series and isolated cases. In this study, we present our prospectively collected patient clinical and epidemiological data in order to provide a proper management
- Conditions
- Spondylodiscitis
- Medical subject headings
- Discitis
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the inflammatory markers in patient with spondylodiscitis (Ex. C reactive protein (CRP) in mg/dl)
collect all patients with spondylodiscitis who come to Assiut University Hospital, measure the inflammatory markers and follow up them after medical or surgical treatment
Measured: collect data for 1 year and follow up for 1 year
Describing of pain severity according to Pain severity scale and follow up after treatment
collect all patients with spondylodiscitis who come to Assiut University Hospital, measure the pain severity and follow up pain improvement after medical or surgical treatment
Measured: collect data for 1 year and follow up for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SpondylodiscitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osama Ahmed Ibrahiem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806905
- Sponsor's protocol ID
- ECFDSAUH
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamal AM, El-Sharkawi MM, El-Sabrout M, Hassan MG. Spondylodiscitis: experience of surgical management of complicated cases after failed antibiotic treatment. SICOT J. 2020;6:5. doi: 10.1051/sicotj/2020002. Epub 2020 Feb 14.
PubMed 32057290D'Agostino C, Scorzolini L, Massetti AP, Carnevalini M, d'Ettorre G, Venditti M, Vullo V, Orsi GB. A seven-year prospective study on spondylodiscitis: epidemiological and microbiological features. Infection. 2010 Apr;38(2):102-7. doi: 10.1007/s15010-009-9340-8. Epub 2010 Feb 27.
PubMed 20191397Kaya S, Kaya S, Kavak S, Comoglu S. A disease that is difficult to diagnose and treat: evaluation of 343 spondylodiscitis cases. J Int Med Res. 2021 Nov;49(11):3000605211060197. doi: 10.1177/03000605211060197.
PubMed 34851766Issa K, Diebo BG, Faloon M, Naziri Q, Pourtaheri S, Paulino CB, Emami A. The Epidemiology of Vertebral Osteomyelitis in the United States From 1998 to 2013. Clin Spine Surg. 2018 Mar;31(2):E102-E108. doi: 10.1097/BSD.0000000000000597.
PubMed 29135608Gerometta A, Bittan F, Rodriguez Olaverri JC. Postoperative spondilodiscitis. Int Orthop. 2012 Feb;36(2):433-8. doi: 10.1007/s00264-011-1442-0. Epub 2012 Feb 4.
PubMed 22307558Sur A, Tsang K, Brown M, Tzerakis N. Management of adult spontaneous spondylodiscitis and its rising incidence. Ann R Coll Surg Engl. 2015 Sep;97(6):451-5. doi: 10.1308/rcsann.2015.0009. Epub 2015 Aug 14.
PubMed 26274746Turgut M. Complete recovery of acute paraplegia due to pyogenic thoracic spondylodiscitis with an epidural abscess. Acta Neurochir (Wien). 2008 Apr;150(4):381-6. doi: 10.1007/s00701-007-1485-6. Epub 2008 Jan 8.
PubMed 18176773
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Clinical Features and Diagnosis of Spondylodiscitis at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05806905
- Acronym / sponsor ID
- ECFDSAUH
- Conditions
- Spondylodiscitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Apr 2023 (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.
The term Spondylodiscitis (SD) involves infection of the vertebra (Spondylitis), infection of the intervertebral disc (Discitis), or both (Spondylodiscitis) Spondylodiscitis is a rare disease accounting for 2.7% of all cases of pyogenic osteomyelitis, with incidence varying from 1 per 100,000/year to 1 per 250,000/year However, there is evidence that the incidence is rising due to longer life expectancy for patients with increasing incidence of chronic debilitating disease including diabetes mellitus, malignancies ,(Human Immunodeficiency Virus (HIV)/ Acquired Immunodeficiency Syndrome (AIDs) , immunosuppressive therapy, increasing numbers of Intravenous drug users , and spinal surgeries.
Pathogens can reach the spine either by: hematogenous spread, direct external inoculation, or spread from contiguous tissues harboring these pathogens. The hematogenous route is the predominant one, allowing seeding of infection from distant sites into the vertebral column.
Since spondylodiscitis has not been studied in a clinical trial at our hospital, and information about this disease has come from retrospective case series and isolated cases. In this study, we present our prospectively collected patient clinical and epidemiological data in order to provide a proper management
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms and radiological findings suggestive of spondylodiscitis
Key inclusion criteria (1 listed)
- All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms suggestive of spondylodiscitis in all age groups including patients with known medical conditions and patients who underwent previous spine surgeries (post operative spondylodiscitis)
Key exclusion criteria (1 listed)
- No patients will be excluded
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
measuring the inflammatory markers in patient with spondylodiscitis (Ex. C reactive protein (CRP) in mg/dl)
Time frame: collect data for 1 year and follow up for 1 year
collect all patients with spondylodiscitis who come to Assiut University Hospital, measure the inflammatory markers and follow up them after medical or surgical treatment
Describing of pain severity according to Pain severity scale and follow up after treatment
Time frame: collect data for 1 year and follow up for 1 year
collect all patients with spondylodiscitis who come to Assiut University Hospital, measure the pain severity and follow up pain improvement after medical or surgical treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 32057290Kamal AM, El-Sharkawi MM, El-Sabrout M, Hassan MG. Spondylodiscitis: experience of surgical management of complicated cases after failed antibiotic treatment. SICOT J. 2020;6:5. doi: 10.1051/sicotj/2020002. Epub 2020 Feb 14.
- Background: PubMed 20191397D'Agostino C, Scorzolini L, Massetti AP, Carnevalini M, d'Ettorre G, Venditti M, Vullo V, Orsi GB. A seven-year prospective study on spondylodiscitis: epidemiological and microbiological features. Infection. 2010 Apr;38(2):102-7. doi: 10.1007/s15010-009-9340-8. Epub 2010 Feb 27.
- Background: PubMed 34851766Kaya S, Kaya S, Kavak S, Comoglu S. A disease that is difficult to diagnose and treat: evaluation of 343 spondylodiscitis cases. J Int Med Res. 2021 Nov;49(11):3000605211060197. doi: 10.1177/03000605211060197.
- Background: PubMed 29135608Issa K, Diebo BG, Faloon M, Naziri Q, Pourtaheri S, Paulino CB, Emami A. The Epidemiology of Vertebral Osteomyelitis in the United States From 1998 to 2013. Clin Spine Surg. 2018 Mar;31(2):E102-E108. doi: 10.1097/BSD.0000000000000597.
- Background: PubMed 22307558Gerometta A, Bittan F, Rodriguez Olaverri JC. Postoperative spondilodiscitis. Int Orthop. 2012 Feb;36(2):433-8. doi: 10.1007/s00264-011-1442-0. Epub 2012 Feb 4.
- Background: PubMed 26274746Sur A, Tsang K, Brown M, Tzerakis N. Management of adult spontaneous spondylodiscitis and its rising incidence. Ann R Coll Surg Engl. 2015 Sep;97(6):451-5. doi: 10.1308/rcsann.2015.0009. Epub 2015 Aug 14.
- Background: PubMed 18176773Turgut M. Complete recovery of acute paraplegia due to pyogenic thoracic spondylodiscitis with an epidural abscess. Acta Neurochir (Wien). 2008 Apr;150(4):381-6. doi: 10.1007/s00701-007-1485-6. Epub 2008 Jan 8.
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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 Spondylodiscitis, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 10 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 Egypt. 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 Mohammed G Hassan, Professor (01001843084, m.gamal@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring the inflammatory markers in patient with spondylodiscitis (Ex. C reactive protein (CRP) in mg/dl) (time frame: collect data for 1 year and follow up for 1 year). 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?
On the ClinicalTrials.gov record for NCT05806905, which also lists 7 linked publications.
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 Apr 2023.