| CTRI Number |
CTRI/2018/12/016729 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
23/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Usefullness of new rapid tool called Cartridge Based Nucelic Acid Amplification Test for diagnosis of tuberculosis in urban tumakuru |
|
Scientific Title of Study
|
Utilization of cartridge based nucelic acid amplification test for presumptive Tuberculosis diagnosis in urban Tumakuru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sphoorthi Narasimhan |
| Designation |
post graduate student |
| Affiliation |
Prasanna School of Public Health,MAHE, Manipal |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9986031244 |
| Fax |
|
| Email |
spoobaradwaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Arathi Rao |
| Designation |
coordinator- MPH programme,MAHE |
| Affiliation |
Prasanna School of Public Health, MAHE, Manipal |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanath Kumar G K |
| Designation |
District tuberculosis officer |
| Affiliation |
|
| Address |
district tuberculosis office, tumkur, opposite to amanikere, behind DHO office, tumkur
Tumkur
KARNATAKA
572101
India |
| Phone |
9449843240 |
| Fax |
|
| Email |
sanathkumargurram@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sphoorthi Narasimhan |
| Address |
prasanna school of public health, manipal academy of higher education, manipal, karnataka |
| Type of Sponsor |
Other [SELF ] |
|
|
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 Sanath Kumar G K |
District Tuberculosis office |
opposite to amanikere,behind DHO office, tumkur
Tumkur
KARNATAKA |
9449843240
sanathkumargurram@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
study is conducted to ask about the utilization pattern, hence questionnaire is asked to CBNAAT operating technician,lab technician, medical officer, hospital manager |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
CB NAAT operating Technician, lab technician, hospital manager, and medical officer |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the utilization of CB NAAT pattern for presumptive diagnosis for drug resistance in tuberculosis in urban Tumakuru |
last week of april |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the utilization of CB NAAT pattern for presumptive diagnosis for drug resistance in tuberculosis in urban Tumakuru |
last week of april |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
21/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
aim of the study is to assess the utilization of CB NAAT
pattern for presumptive diagnosis for drug resistance in tuberculosis in urban
Tumakuru. complete enumeration of all techinician operating CB NAAT, lab technician, hospital manager and medical officer in case of absenece of lab technician to answer about the utilization of CB NAAT. the outcome of the study is to understand the utilization pattern of CB NAAT. |