| CTRI Number |
CTRI/2024/04/066493 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Commoness of Brain infections during and after COVID 19 era |
|
Scientific Title of Study
|
Prevalence of Central Nervous system infections in the COVID 19 and post COVID 19 period |
| 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 Dinesh Upadhya |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room no 1,Centre for Molecular Neurosciences,
Kasturba Medical College, Manipal,Udupi- 576104, Karnataka, India
Room no 1, Centre for Molecular Neurosciences,
Kasturba Medical College, Manipal,Udupi- 576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8747012060 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Upadhya |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room no. 1, Centre for Molecular Neurosciences,
Kasturba Medical College, Manipal,Udupi 576104, Karnataka, India
Room no.1, Centre for Molecular Neurosciences,
Kasturba Medical College, Manipal,Udupi 576104, Karnataka, India
KARNATAKA
576104
India |
| Phone |
8747012060 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Upadhya |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Centre for Molecular Neurosciences,
Kasturba Medical College, Manipal,Udupi. 576104, Karnataka, India
Centre for Molecular Neurosciences,
Kasturba Medical College, Manipal,Udupi 576104 Karnataka, India
KARNATAKA
576104
India |
| Phone |
8747012060 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Madhav Nagar, Manipal, Udupi- 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Self sponsored |
| Address |
Dr. Dinesh Upadhya, Centre for Molecular Neurosciences
Kasturba Medical college, Madhav Nagar, Manipal, Udupi 576104, Karnataka, India
Manipal
Udupi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Aswathi Ramesh |
Kasturba Medical College and Kasturba Hospital |
Madhav Nagar
Manipal
Udupi 576104, Karnataka, India
Udupi
KARNATAKA |
9455025411
aswathi.ramesh2@learner.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: G009||Bacterial meningitis, unspecified, (2) ICD-10 Condition: G053||Encephalitis and encephalomyelitisin diseases classified elsewhere, (3) ICD-10 Condition: G049||Encephalitis, myelitis and encephalomyelitis, unspecified, (4) ICD-10 Condition: G062||Extradural and subdural abscess, unspecified, (5) ICD-10 Condition: G07||Intracranial and intraspinal abscess and granuloma in diseases classified elsewhere, (6) ICD-10 Condition: G08||Intracranial and intraspinal phlebitis and thrombophlebitis, (7) ICD-10 Condition: G01||Meningitis in bacterial diseases classified elsewhere, (8) ICD-10 Condition: G02||Meningitis in other infectious andparasitic diseases classified elsewhere, (9) ICD-10 Condition: G039||Meningitis, unspecified, (10) ICD-10 Condition: G048||Other encephalitis, myelitis and encephalomyelitis, (11) ICD-10 Condition: G09||Sequelae of inflammatory diseasesof central nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with all age groups (Newborn to 90
years old) diagnosed with Central Nervous
System infections based on clinical features
and initial CSF and neuro-imaging results at
Kasturba Hospital, Manipal, between 01
November 2020- 31 September 2023 |
|
| ExclusionCriteria |
| Details |
Central Nervous System infections not
suspected or criteria for Central Nervous
System infections not met.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Individual data of various Central Nervous System infections in a tertiary care hospital will be
recorded |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Individual data of various Central Nervous System infections during COVID 19 and post COVID 19 period |
1 year |
|
|
Target Sample Size
|
Total Sample Size="972"
Sample Size from India="972"
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)
|
15/05/2024 |
| 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
|
This study is relevant because the majority of the literature available regarding these central nervous system infectious diseases is based on populations from developed countries. There is a regional and seasonal variability in parameters like incidence, clinical presentation, etiology, response to treatment, etc. Therefore, specific regional data is absolutely essential to afford the best-suited medical support and healthcare to our patients, and this study aims to try and fulfill, at least to a certain extent, the menacing research gap that underlies its lack even in the best of our healthcare institutions |