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CTRI Number  CTRI/2019/11/021973 [Registered on: 13/11/2019] Trial Registered Prospectively
Last Modified On: 12/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Targeted NGS (tNGS) Solutions kit Evaluation for Diagnosis of Drug Resistant TB 
Scientific Title of Study   Multi-centre Clinical Trial to Assess the Performance of Culture-free, End-to-end Targeted NGS (tNGS) Solutions for Diagnosis of Drug Resistant TB (DR-TB) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Camilla Rodrigues 
Designation  Consultant Microbiologist 
Affiliation  P D Hinduja National Hospital and MRC 
Address  Dept. of Microbiology, 5th floor, S1, Lalitha Girdhar, Veer Savarkar Marg, Mahim West

Mumbai
MAHARASHTRA
400016
India 
Phone  02224447795  
Fax    
Email  dr_crodrigues@hindujahospital.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Camilla Rodrigues 
Designation  Consultant Microbiologist 
Affiliation  P D Hinduja National Hospital and MRC 
Address  Dept. of Microbiology, 5th floor, S1, Lalitha Girdhar, Veer Savarkar Marg, Mahim West

Mumbai
MAHARASHTRA
400016
India 
Phone  02224447795  
Fax    
Email  dr_crodrigues@hindujahospital.com  
 
Details of Contact Person
Public Query  
Name  Dr Camilla Rodrigues 
Designation  Consultant Microbiologist 
Affiliation  P D Hinduja National Hospital and MRC 
Address  Dept. of Microbiology, 5th floor, S1, Lalitha Girdhar, Veer Savarkar Marg, Mahim West

Mumbai
MAHARASHTRA
400016
India 
Phone  02224447795  
Fax    
Email  dr_crodrigues@hindujahospital.com  
 
Source of Monetary or Material Support  
Foundation for Innovative New Diagnostics FIND , 9th Floor, Vijaya Building 17, Barakhamba Road, New Delhi, 110001 
 
Primary Sponsor  
Name  Foundation for Innovative New Diagnostics FIND 
Address  9th Floor, Vijaya Building 17, Barakhamba Road, New Delhi, 110001 
Type of Sponsor  Other [NGO Partner with RNTCP of India] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Georgia
India
South Africa  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Camilla Rodrigues  Hinduja Hospital  P D Hinduja National Hospital and Medical Research Centre,
Mumbai
MAHARASHTRA 		 02224447785

dr_crodrigues@hindujahospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Liquid culture DST and First line & second line line probe assay.  Diagnostic evaluation of the tNGS assays will be done in comparison with the existing diagnostics assays. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. A clear TB-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra prior to enrolment, irrespective of RIF-resistance status,

AND
2. At risk for drug resistant TB based on at least one of the following risk factors:

A.Not responding TB treatment with positive sputum smear or culture after ≥ 3 months of standard TB treatment.
OR
B.Previously diagnosed with Rif-resistant/MDR-TB and failed TB treatment with positive sputum smear or culture after ≥ 3months of a standard MDR-TB regiment
OR
C.Previously received >1 month of treatment for a prior TB episode
OR
D.Close contact with a known drug-resistant TB case
AND
3.Willing to provide sputum
AND
4.Over 18 years of age (or legal adult age corresponding to the site)
5.Provision of signed informed consent


 
 
ExclusionCriteria 
Details  1. Have started treatment for current TB episode more than 7 days prior to date of enrolment (i.e. must have been on treatment for less than 7 days for this TB treatment episode at enrolment)
OR
2. Are pregnant or institutionalized or imprisoned
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Point estimates, with 95% confidence intervals, of sensitivity and specificity for rifampicin, isoniazid, fluoroquinolones, second-line injectables, and pyrazinamide resistance detection for up to 3 tNGS solutions  Sputum samples will be collected from patient on the day of enrolment and the following day (Day 1 and Day 2) and pooled together to generate sediment. Frozen sediments will be processed using end-to-end targeted sequencing solutions no later than 1 month after collection. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Detecting sensitivity and specificity (95%) for second-line resistance detection (bedaquiline, linezolid, clofazamine, streptomycin).
2. Performance of overall test success rate against Xpert MTB/RIF and Hain MTBDRplus/sl.
3. Performance characteristics including invalid and indeterminate rates, ease of use metrics, and other operational characteristics.
 		 12 months 
 
Target Sample Size   Total Sample Size="700"
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)   01/03/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2020 
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)   Not Yet Recruiting 
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   The purpose of this observational multi-centre clinical study is to determine the performance accuracy and assess the operational characteristics of up to 3 tNGS end-to-end targeted sequencing solutions for DR-TB diagnosis at settings of intended use. It will be carried out at study sites in India, South Africa, and Georgia. The data obtained through this trial will be used only for evaluation of the accuracy and operational characteristics of tNGS solutions and will not be used in any way to inform the treatment of patients enrolled in the trial.
 
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