| CTRI Number |
CTRI/2018/06/014611 [Registered on: 25/06/2018] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
TB portal for Indian tuberculosis patients |
|
Scientific Title of Study
|
Establishing TB portal of Mycobacterium tuberculosis patients from tertiary care hospital in Southern India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahadev Rao |
| Designation |
Professor |
| Affiliation |
MAHE |
| Address |
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahadev Rao |
| Designation |
Professor |
| Affiliation |
MAHE |
| Address |
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mahadev Rao |
| Designation |
Professor |
| Affiliation |
MAHE |
| Address |
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CRDF |
| Address |
NIAID/NIH
5601, Fishers Lane Rm 4A22
Rockville, MD USA 20852 |
| Type of Sponsor |
Government funding agency |
|
|
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 Mahadev Rao |
Kasturba Medical College |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education,Manipal
Udupi
KARNATAKA |
8105706060
mahadev.rao@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| MAHE Ethics Committee |
Approved |
| MAHE Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Tuberculosis, (1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All pulmonary Tb Patients admitted in Hospital are considered for the study |
|
| ExclusionCriteria |
| Details |
Terminally ill cancer Patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MDR positive or negative |
3,6,12,24,48 months after first Diagnosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Death |
Time till follow up |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/06/2018 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
During and after the study, the data will be published in TB portal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
1. Justification for study Centralized databases, curated from collaborative efforts of TB endemic countries can help the researchers identify global trends and important biological features which would be only possible by comprehensive analysis of combined data. On an average, 677 cases are being presented in KMC Manipal every year from 2012-2016. The data from these many cases can be a lucrative for TB portal. Implementation of the TB portal will also enable us to follow-up all the patients. This will have an improved patient outcome assessment by measuring the medication adherence and treatment outcome. The genomic data obtained will help in identifying the genome of TB resistant strains of the region specific TB cases. We carried out whole genome sequencing of 246
culture confirmed Mycobacterium tuberculosis clinical samples
(convenient cohort sampling) from TB patients of Kasturba Hospital, Manipal and
Udupi district Hospital, which are 2 major referral hospitals of Udupi
district, Karnataka state.
|