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CTRI Number  CTRI/2020/02/023108 [Registered on: 04/02/2020] Trial Registered Prospectively
Last Modified On: 12/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Two-month Regimens using new combinations for drug sensitive Tuberculosis. 
Scientific Title of Study   Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for drug-sensitive Tuberculosis (TB) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03474198  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Sarin 
Designation  Director 
Affiliation  National Insititute of Tuberculosis and Respiratory Diseases 
Address  Director Room, Administrative Block,Department of TB and Chest, Sri Aurobindo Marg, Near Qutub Minar, New Delhi

South
DELHI
110030
India 
Phone  01126963335  
Fax    
Email  r.sarin@nitrd.nic.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Prabhpreet Sethi 
Designation  Chest Specialist Gr-1 
Affiliation  National Insitute of Tuberculosis and Respirtory Diseases 
Address  Room No. 4, Robert Koch Research Block, Department of TB and Chest,Sri Aurobindo Marg, Near Qutub Minar, New Delhi

South
DELHI
110030
India 
Phone  9968662074  
Fax    
Email  p.sethi@nitrd.nic.in  
 
Details of Contact Person
Public Query  
Name  Dr Prabhpreet Sethi 
Designation  Chest Speialist Gr-1 
Affiliation  National Insitute of Tuberculosis and Respiratory Diseases 
Address  Room No. 4, Robert Koch Research Block, Department of TB and Chest, Sri Aurobindo Marg, Near Qutub Minar, New Delhi

South
DELHI
110030
India 
Phone  9968662074  
Fax    
Email  p.sethi@nitrd.nic.in  
 
Source of Monetary or Material Support  
University College of London 
 
Primary Sponsor  
Name  UNIVERSITY COLLEGE OF LONDON 
Address  Gower St, Bloomsbury, London WC1E 6BT, United Kingdom 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Philippines
Indonesia
Singapore
Thailand
India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Solanki  B. J. Medical College and Civil Hospital  Department of Pulomnary Medicine, HOD Room, B. J. Medical COllege and Civil Hospital, Ahmedabad, Gujarat
Ahmadabad
GUJARAT 		 07922683067

dean-bjmc-ahm@gujarat.gov.in 
Dr Prabhpreet Sethi  National Institute of Tuberculosis and Respiratory Diseases  Room No. 4, Robert Koch Research Block, Department of TB and Chest, Sri Aurobindo Marg, Near Qutub Minar, New Delhi
South
DELHI 		 9968662074

p.sethi@nitrd.nic.in 
Dr Syed Hissar  National Instiute of Research in Tuberculosis  Department of Clinical Research, No. 1 Mayor Satyamoorthy Road, Chetput, Chennai 600031
Chennai
TAMIL NADU 		 04428369500

directornirt@nirt.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
B. J. Medical College and Civil Hospital Ahmedabad  Approved 
National Institute For Research in Tuberculosis Chennai  Approved 
National Institute of Tuberculosis and Respiratory Diseases New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Novel Combinations to Augment Treatment Effectiveness for drug-sensitive Tuberculosis  Regimen B: Rifampicin (35mg/kg), isoniazid, pyrazinamide, ethambutol, linezolid Regimen C: Rifampicin (35mg/kg), isoniazid, pyrazinamide, ethambutol, clofazimine Regimen D: Rifapentine, isoniazid, pyrazinamide, linezolid, levofloxacin Regimen E: Isoniazid, pyrazinamide, ethambutol, linezolid, bedaquiline. 
Comparator Agent  Novel Combinations to Augment Treatment Effectiveness for drug-sensitive Tuberculosis  Standard combination treatment for pulmonary TB of 8 weeks rifampicin, isoniazid, pyrazinamide, ethambutol, then 16 weeks rifampicin, isoniazid, Ethambutol only 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinical symptoms consistent with pulmonary TB and/or evidence of pulmonary TB on chest X-ray (CXR)
Sputum GeneXpert test positive
Willing to comply with the study visits and procedures
Resident at a fixed address
Willing to have directly observed therapy
Willing and able to provide written informed consent 
 
ExclusionCriteria 
Details  Taken more than 10 daily doses of standard antiTB medication or fluoroquinolones during the 3 months prior to randomisation
Previous active TB disease for which treatment was given prior to the current episode
Known or suspected extrapulmonary TB
Severe clinical pulmonary TB
Sputum smear 3+ on microscopy
Cavity size > 4cm on screening CXR
Presence of rifampicin resistance on GeneXpert test
Poorlycontrolled diabetes that, in the opinion of the investigator, is unlikely to be controlled with available management strategies
Active malignancy requiring systemic chemotherapy or radiotherapy
Known Hepatitis B surface antigen positive and/or HCV antibody positive, unless liver function tests consistently within normal range for at least 2 years
History of myocardial infarction, congestive cardiac failure, cardiac arrhythmias or any known congenital cardiac problems
History of severe chronic lung disease with symptom score of less than or equal to 3 on MRC breathlessness scale
History of seizures
Current tendinitis or history of tendinopathy associated with fluoroquinolone use
Symptomatic peripheral neuropathy causing greater than minimal interference with usual social and functional activities
Current alcohol or drug abuse
Women who are currently pregnant or breastfeeding
Women of childbearing potential unwilling or unable to use appropriate effective contraception for the first 6 months of the trial
Known allergy to one or more of the study drugs
Taking a concomitant medication that has a known or predicted interaction with any of the study drugs to which the patient might be randomised, or is known to prolong the QTc interval
Taking any immunosuppressive drugs or use of systemic corticosteroids for more than 2 weeks prior to screening
Colour blindness detected by Ishihara test
12lead ECG at screening shows QTc greater than 450ms and/or any other clinicallysignificant abnormality such as arrhythmia or ischaemia
HIV antibody positive at screening
Any other significant condition, that would, in the opinion of the investigator, compromise the patients safety or outcome in the trial or lead to poor compliance with study visits and protocol requirements
Participation in other clinical intervention trial or research protocol 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Unsatisfactory clinical outcome at week 96 after randomisation.
As defined by ongoing requirement for TB treatment at week 96 OR ongoing TB disease activity at week 96 (clinical, microbiological and/or imaging evidence) OR death before week 96 		 96 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Acceptability of the strategy using trialspecific questionnaire
Total days on TB drug treatment
Time off work or study due to illness/treatment
Total Quality of life using MOSHIV questionnaire
Respiratory disability at week 96
Total Grade 3 or 4 clinical adverse events
Total serious adverse events
Death
Adherence to TB medication
Acquired drug resistance by week 96
Community transmission risk  		 96 weeks 
 
Target Sample Size   Total Sample Size="900"
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/03/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="11"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months, although patients often fail to adhere to the long treatment, leading to poor clinical outcomes including drug resistance, which is expensive and difficult to treat.

The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy) comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical response) with a regimen predicted to have enhanced sterilising activity ("boosted regimen") and monitoring closely after treatment cessation. Those who relapse (predicted to be always drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.

The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If non-inferiority is demonstrated then the advantages/disadvantages of implementing the strategy will be explored in secondary outcomes (from patient and programme perspective).

The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens include new drugs (licensed drugs, repurposed from other indications) and optimized doses of standard drugs, selected based on consideration of maximal sterilising effect, absence of drug-drug interactions, as well as safety and tolerability over a period of 2 months

 
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