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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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

 
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