| CTRI Number |
CTRI/2024/03/064730 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Performance Evaluation of Abbott TB Rapid Test |
|
Scientific Title of Study
|
A Multi-centric Performance Evaluation of Diagnostic Accuracy of
Determineâ„¢ TB LAM Ag Test, a Point-of-Care Urine
Lipoarabinomannan Assay, for detection of Active Tuberculosis in
People Living with HIV in India |
| Trial Acronym |
Not Applicable |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NITRD/RC/2023/539-Version 1.3 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upasna Agarwal |
| Designation |
Head Department Medicine and of Internal In charge ART Centre |
| Affiliation |
National Institute Of Tuberculosis and Respiratory Diseases |
| Address |
Head, Dept. of Internal Medicine & In Charge ART and ICTC Centre National Institute of TB and Respiratory Diseases,
Sri Aurobindo Marg, New Delhi 110030, INDIA
South West
DELHI
110030
India |
| Phone |
01169027100 |
| Fax |
01169027100 |
| Email |
u.agarwal@nitrd.nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upasna Agarwal |
| Designation |
Head Department Medicine |
| Affiliation |
National Institute Of Tuberculosis and Respiratory Diseases |
| Address |
Head, Dept. of Internal Medicine &
In Charge ART and ICTC Centre
National Institute of TB and Respiratory Diseases,
Sri Aurobindo Marg, New Delhi 110030, INDIA
South West
DELHI
110030
India |
| Phone |
01169027100 |
| Fax |
01169027100 |
| Email |
u.agarwal@nitrd.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upasna Agarwal |
| Designation |
Head Department Medicine |
| Affiliation |
National Institute Of Tuberculosis and Respiratory Diseases |
| Address |
Head, Dept. of Internal Medicine &
In Charge ART and ICTC Centre
National Institute of TB and Respiratory Diseases,
Sri Aurobindo Marg, New Delhi 110030, INDIA
South West
DELHI
110030
India |
| Phone |
01169027100 |
| Fax |
01169027100 |
| Email |
u.agarwal@nitrd.nic.in |
|
|
Source of Monetary or Material Support
|
| Abbott Rapid Diagnostics India |
|
|
Primary Sponsor
|
| Name |
Abbott Diagnostics Medical Pvt Ltd |
| Address |
DSM 221 & DSM 222, DLF Towers, Shivaji Marg, Najafgarh Road,
New Delhi – 110015, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dolanchampa Modak |
Calcutta School Of Tropical Medicine |
Room No. 108,
Chittaranjan Ave, Calcutta
Medical College, College
Square, Kolkata
Kolkata
WEST BENGAL |
03322123697
drdolanmodak@gmail.com |
| Dr Durgaprasad Sadhupati |
Government Medical College and Government General Hospital |
Government Medical College and Government General Hospital, Ramanagar, Ongole 523001 Prakasam, Andhra Pradesh, India
Prakasam
ANDHRA PRADESH |
08662452244
durgaprasadsadupati@gmail.com |
| Dr Arunachalam |
Government Mohan Kumaramangalam Medical College Hospital |
8,Fort Main Rd, Shevapet, Salem, Tamil Nadu 636002, Salem, Tamil Nadu 636002
Salem
TAMIL NADU |
8610890989
artsalem@gmail.com |
| Dr Chiranjjita Phukan |
Guwahati Medical College |
Narakasur Hilltop, Bhangagarh, Guwahati781032, Assam, India, Kamrup Metropolitan, Assam – 781032
Kamrup
ASSAM |
03612452244
chiranjita7j@gmail.com |
| Dr Upasna Agarwal |
National Institute Of Tuberculosis and Respiratory Diseases |
Dept. of Internal Medicine & ART and ICTC Centre National Institute of TB and Respiratory Diseases,
Sri Aurobindo Marg, New Delhi 110030, INDIA
South West
DELHI |
011-69027100
u.agarwal@nitrd.nic.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Calcutta School of Tropical Medicine |
Approved |
| Institutional Ethics Committee Govt.Medical College & Government General Hospital, Bhagya Nagar, Ongole, Prakasam, Andhra Pradesh |
Approved |
| Institutional Ethics Committee, GMCH |
Approved |
| Institutional Ethics Committee, Govt. Mohan Kumaramangalam Medical College Steel Plant Road Sarkar Kollappatty Salem |
Approved |
| L.R.S Institute of Tuberculosis and Repiratory Diseases |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Composite Reference Standard (CRS), i.e., the standard for
diagnosis of active TB disease, commonly called the ‘gold’ standard in
diagnostic accuracy studies, based on the NTEP definitions |
The CRS for this study is as follows:
• A study participant will be said to have ‘Active TB disease’ if he is
diagnosed to have one of the below:
EITHER
i) Microbiologically confirmed TB based on a biological
specimen being positive for acid fast bacilli, or positive for
Mycobacterium tuberculosis on culture, or positive for
tuberculosis through Rapid Diagnostic molecular test
OR
ii) Clinically diagnosed TB based on X-ray, other radiological,
cytological, histo-pathological abnormalities or presence of
clinical signs with a decision to treat the patient with a full
course of Anti-TB treatment made by a clinician, in absence of
microbiological confirmation
Conversely, those study participants will be said to have ‘No TB
disease’ if they are found to have NO symptoms of TB (4S negative) AND have NO microbiological, radiological, cytological, histopathological
or clinical abnormalities suggestive of active TB as per
NTEP definitions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
HIV positive status and CD4 count ≤ 200 cells/ mm3 |
|
| ExclusionCriteria |
| Details |
Individual currently under anti-tuberculosis treatment (ATT) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic performance evaluation of Determine TB LAM Ag Test |
This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 and complete on or before Mar 2025 and result analysis will be done within Mar/Apr 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A point-of-Care urinary LAM assay, for detection of active TB disease in people living with HIV (PLHIV) with CD4 counts less than or equal to 200 cells/mm in India |
This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 & complete on or before Mar 2025 & result analysis will be done within Mar/Apr 2025 |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
30/03/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A Multi-centric Evaluation of Diagnostic Accuracy of Determineâ„¢ TB LAM Ag Test, a Point-of-Care Urine Lipoarabinomannan Assay, for detection of Active Tuberculosis in People Living with HIV in India.
The Determineâ„¢ TB LAM Ag Test is an in vitro, point-of-care, visually read, qualitative immunoassay for the detection of Lipoarabinomannan (LAM) antigen of Mycobacteria in human urine as an aid in the diagnosis of active TB disease. It is a urine test kit, results of which are visually read as positive or negative depending on visibility or non-visibility of a purple/ grey line, which is indicative of level of LAM antigen of Mycobacteria present in the sample.
Objective of Study - The aim of the study is to evaluate the diagnostic accuracy of the Determineâ„¢ TB LAM Ag Test, a point-of-Care urinary LAM assay, for detection of active TB disease in people living with HIV (PLHIV) with CD4 counts less than or equal to 200 cells/mm3in India.
The study has been approved by CDSCO and Expert Committee on 1st Mar 2024 |