| CTRI Number |
CTRI/2023/10/058448 [Registered on: 09/10/2023] Trial Registered Prospectively |
| Last Modified On: |
30/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify the different microbiological causes of spondylodiscitis |
|
Scientific Title of Study
|
A study to determine the aetiology of Infectious Spondylodiscitis and to
develop a diagnostic scoring system |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsha Choudary Mutthineni |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room No.-10, Department of Infectious Diseases, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7893934985 |
| Fax |
|
| Email |
mharshachoudary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha Saravu |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room No.-03, Department of Infectious Diseases, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448107636 |
| Fax |
|
| Email |
kavitha.saravu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavitha Saravu |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room No.-03, Department of Infectious Diseases, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9448107636 |
| Fax |
|
| Email |
kavitha.saravu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavitha Saravu |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
Room No.- 3, Department of Infectious Diseases, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9448107636
kavitha.saravu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M463||Infection of intervertebral disc (pyogenic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIl |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who were confirmed to have infectious involvement in the spine
2. Patients with a microbiologically confirmed diagnosis and an MRI image taken at
the time of diagnosis. |
|
| ExclusionCriteria |
| Details |
Postoperative spine infections or infections related to implants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will determine the aetiology of the infectious spondylodiscitis |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generate a diagnostic scoring algorithm for the infectious Spondylodiscitis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spondylodiscitis is an infectious inflammation that affects vertebral discs and adjacent structures. It is induced by a broad spectrum of pathogens, including both tubercular and bacterial infections such as Brucella spp., Staphylococcus spp., Streptococcus spp., and Enterobacteriaceae. Infectious spondylodiscitis (IS) is a condition that presents a diagnostic dilemma and mandates prolonged treatment. It has been diagnosed with alarming frequency over the past decade. Data from a United Kingdom (UK) census shows a 150% increased incidence of IS in the past decade compared to the previous decades(1). This could reflect the increased number of invasive spinal procedures in the recent past and the expansion in the elderly and immunocompromised population as well. Early diagnosis and treatment become crucial as the disease can have potentially irreversible neurologic consequences. Despite this disease’s increased incidence and prevalence in India, the diagnosis is usually delayed in most of these cases. Hence this study is designed to develop a diagnostic algorithm for infectious spondylodiscitis. |