| CTRI Number |
CTRI/2020/04/024423 [Registered on: 01/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to find markers in blood and cerebrospinal fluid to help diagnose tuberculosis of the brain |
|
Scientific Title of Study
|
Identification of Biomarkers for Central Nervous System Tuberculosis |
| Trial Acronym |
CNSTB STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr jeyaraj Durai Pandian |
| Designation |
Principal and Professor |
| Affiliation |
Christian Medical College and Hospital, Ludhiana |
| Address |
Department of Neurology, Christian Medical College and Hospital
Principal Office, Christian Dental College and Hospital, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr jeyaraj Durai Pandian |
| Designation |
Principal and Professor |
| Affiliation |
Christian Medical College and Hospital, Ludhiana |
| Address |
Department of Neurology, Christian Medical College and Hospital
Principal Office, Christian Dental College and Hospital, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ivy Anne Sebastian |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College and Hospital, Ludhiana |
| Address |
Department of Neurology, Christian Medical College and Hospital
Doctors Duty room, Neurology Department, christian Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9999464986 |
| Fax |
|
| Email |
ivysebastiancmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University Hospital Frankfurt |
|
|
Primary Sponsor
|
| Name |
University Hospital Frankfurt |
| Address |
Clinic or Neurology
Schleusenweg 2-16
60528 Frankfurt |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeyaraj Durai Pandian |
Christian Medical College and Hospital |
Ground Floor , Neurology Office
Department of Neurology
Ludhiana
PUNJAB |
9915784750
jeyarajpandian@hotmail.com |
| Dr Manish Modi |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH |
Department of Neurology
Nehru building Ground Floor
PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH |
9876197533
modipgi@gmail.com |
| Dr Ivy Anne Sebastian |
St.Stephens Hospital |
Room No:2003, Second Floor, Department of Neurology, St. Stephens Hospital, Tis Hazari
North
DELHI |
9999464986
011-23932412
ivy29cmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Christian Medical College and Hospital , Ludhiana |
Approved |
| Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
| St. Stephens Hospital Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Clinically suspected Central Nervous System Tuberculosis
|
|
| ExclusionCriteria |
| Details |
• Informed consent not given
• Lumbar puncture not possible/not performed before start of treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of biomarkers for differentiating CNS Tb and clinically relevant differential diagnosis (sarcoidosis, lymphoma, other infectious cause)
|
Baseline ( Date of Patient Enrollment ) and follow-up at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of biomarkers at 6 month follow up for treatment success and clinical outcome |
Baseline ( Date of Patient Enrollment ) and follow-up at 6 months |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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)
|
01/04/2020 |
| 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
Modification(s)
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rationale:
Tuberculosis
(Tb) is still the leading cause of death from infectious disease. Although
cases have declined over the last decades, the emergence of multi drug
resistant strains is causing an increasing problem.
Aims/
Hypothesis:
Aim
is to identify biomarkers of Central Nervous System Tuberculosis in both CSF
and Serum to diagnose.
Methods
& Design:
It
is a Prospective, multicenter trial including 3 centers. Patient
≥ 18 years of age and clinically suspected Tb will be included for a period of
1 year. 108 patients with confirmed and 108 with suspected but ruled out Tb of
CNS will be included. Blood will be
collected at Visit 1 and after 6 month at Visit 2. Cerebrospinal fluid will
only be collected at Visit 1. Clinically data will be collected in all patients
including CSF examination and MRI. Sample size collection will be performed by
the independent with test. Statistical Package for the Social Sciences (SPSS)
will be used for statistical analysis.
Primary endpoints include diagnostic accuracy of biomarkers for
differentially CNS Tb and at 6 months follow up for treatment success and
clinical outcome.
Summary:
Establishing
a single biomarker or a combination of biomarkers to distinguish CNS Tb from
its most important differential diagnoses would significantly simplify both
diagnostics and treatment.
|