CTRI Number |
CTRI/2019/09/021240 [Registered on: 13/09/2019] Trial Registered Prospectively |
Last Modified On: |
12/09/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
To assess the diagnostic performance of a new method for quick detection of tuberculosis and its resistance to anti TB drugs like rifampicin and isoniazid |
Scientific Title of Study
|
Multicentre trial to assess the performance of centralized assay solutions for detection of MTB and resistance to Rifampin and Isoniazid (Protocol Version Number v3.0)
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sanghamitra Pati |
Designation |
Scientist G and Director |
Affiliation |
ICMR Regional Medical Research Centre, Bhubaneswar |
Address |
ICMR Regional Medical Research Centre P.O. South Eastern Railways Complex Bhubaneswar P.O. South Eastern Railways Complex Bhubaneswar 751023
Khordha ORISSA 751023 India |
Phone |
6742301322 |
Fax |
6742301351 |
Email |
drsanghamitra12@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Dasarathi Das |
Designation |
Scientist F |
Affiliation |
ICMR Regional Medical Research Centre, Bhubaneswar |
Address |
ICMR Regional Medical Research Centre P.O. South Eastern Railways Complex Bhubaneswar
Khordha ORISSA 751023 India |
Phone |
6742305626 |
Fax |
|
Email |
drdas60@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jyotirmayee Turuk |
Designation |
Scientist-C |
Affiliation |
ICMR Regional Medical Research Centre, Bhubaneswar |
Address |
ICMR Regional Medical Research Centre P.O. South Eastern Railways Complex Bhubaneswar
Khordha ORISSA 751023 India |
Phone |
6742305626 |
Fax |
|
Email |
drjyotirmayeeturuk@gmail.com |
|
Source of Monetary or Material Support
|
Foundation for Innovative New Diagnostics New Delhi and Regional Medical Research Centre Bhubaneswar |
|
Primary Sponsor
|
Name |
Foundation for Innovative New Diagnostics |
Address |
Flat No. 8, 9th Floor, Vijaya Building, 17 Barakhamba Road, New Delhi- 110001 |
Type of Sponsor |
Other [FIND India is compliant with the Foreign Contribution (Regulation) Act (FCRA).] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India Germany Republic of Moldova South Africa |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR DASARATHI DAS |
Out Patient Department ICMR REGIONAL MEDICAL RESEARCH CENTRE |
Room No.103 Designated Microscopy Centre Regional Medical Research Centre EASTERN RAILWAYS COMPLEX BHUBANESWAR 751023 Khordha ORISSA |
9437920085 6742301351 drdas60@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ICMR REGIONAL MEDICAL RESEARCH CENTRE BHUBANESWAR INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Aged 18 years or more
Clinical suspicion of pulmonary TB including cough ≥2 weeks and any other symptom typical of pulmonary TB listed below
Fever
Malaise
Recent weight loss
Night sweats
Contact with active case
Haemoptysis
Chest pain
Loss of appetite
|
|
ExclusionCriteria |
Details |
Unwilling or unable to provide informed consent
Unwilling to provide two sputum specimens at enrolment
Patients with only extra-pulmonary TB signs & symptoms
Receipt of any dose of TB treatment within 6 months prior to enrolment
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Diagnostic accuracy for MTB detection: clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.
Diagnostic accuracy for RIF/INH detection: clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing
|
seven days
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Diagnostic accuracy for MTB detection: clinical point estimates of sensitivity and specificity measured against mycobacterial culture as the reference standard by subgroup.
Operational characteristics: description of operator experience with the assays through daily observed usage anduser appraisal questionnaires
|
42 days |
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="334"
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
|
Phase 2 |
Date of First Enrollment (India)
|
04/11/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
20/05/2019 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Tuberculosis (TB) is
one of the commonest communicable diseases and a leading cause of mortality and
morbidity worldwide, especially in developing countries. World Health
Organization (WHO) in 2016 considered TB as the top infectious killer which caused
1.8 million deaths in the year 2015. As per Global TB Report 2016, India has
2.8 million new cases of TB and 1,30,000 cases of MDR TB annually. It has also
highest TB-HIV co-morbidity in the world and an estimated 1.1 lakh HIV
associated TB occurred in 2015 and 37,000 estimated number of patients died
among them. In order to control TB, a highly specific and sensitive rapid
diagnostic test is prerequisite for early and effective treatment of TB
patients there by breaking the transmission chain. In December 2010, WHO
recommended use of CB-NAAT for detection of TB and rifampicin resistance in clinical specimens. In order to know the isoniazid sensitivity
additionally, the smear positive sputum specimens were subjected Line Probe Assays (LPAs). Hence combining the
two tests the turnaround time takes about 5-6 days usually in programmatic
condition. However, while the simplicity of the design (from the operator
perspective) is a key advantage in many settings, it is less crucial in
relatively well-equipped centralized laboratories. Instrument/assay
combinations that are designed for this level of the healthcare system should
in principle is able to achieve similar performance with higher throughput and
at a lower per-sample cost – a key advantage in the resource-limited settings
where TB is most common and where highly decentralised testing is economically
unfeasible. Several novel assays have been recently developed/CE-marked that
are all aimed at use in centralized laboratories with potential for high sample
throughput and high accuracy for detection of MTB as well as RIF- and
INH-resistance. However, published data on their performance and operational
characteristics is extremely limited. This study may help immensely to the TB
elimination programme of India as high through put and less TAT are the
predominant characteristic of the intended study |