| CTRI Number |
CTRI/2019/01/017310 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
07/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Study on Tuberculosis resistant to treatment |
|
Scientific Title of Study
|
Evaluation of the Efficacy and Safety of a Combination regimen of Bedaquiline, Delamanid, Linezolid and Clofazimine in Adults with Pre-extensive (Pre-XDR) and
Extensively Drug-resistant Pulmonary Tuberculosis (XDR-TB):Prospective Cohort Study
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| Version Number: 3.1, Version 3.1, Dated: 23-August -2018 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
C Padmapriyadarsini |
| Address |
Department of Clinical Research,
Room No. 5, Clinic Building,
No.1, Mayor VR Ramanathan Road, Chetput, Chennai
Department of Clinical Research,
Room No. 5, Clinic Building,
No.1 Mayor Sathyamoorthy Road, Chetput, Chennai 600 031
Chennai
TAMIL NADU
600031
India |
| Phone |
044-28369503 |
| Fax |
044-28362525 |
| Email |
darsini69@hotmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
C Padmapriyadarsini |
| Address |
Department of Clinical Research,
Room No. 5, Clinic Building,
No.1, Mayor VR Ramanathan Road, Chetput, Chennai
Department of Clinical Research,
Room No. 5, Clinic Building,
No.1 Mayor Sathyamoorthy Road, Chetput, Chennai 600 031
Chennai
TAMIL NADU
600031
India |
| Phone |
044-28369503 |
| Fax |
044-28362525 |
| Email |
darsini69@hotmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
C Padmapriyadarsini |
| Address |
Department of Clinical Research,
Room No. 5, Clinic Building,
No.1, Mayor VR Ramanathan Road, Chetput, Chennai
Department of Clinical Research,
Room No. 5, Clinic Building,
No.1 Mayor Sathyamoorthy Road, Chetput, Chennai 600 031
Chennai
TAMIL NADU
600031
India |
| Phone |
044-28369503 |
| Fax |
044-28362525 |
| Email |
darsini69@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| U.S. Agency for International Development
Ronald Reagan Building
1300 Pennsylvania Ave
Washington, D.C. 20523-0016
United States of America
|
|
|
Primary Sponsor
|
| Name |
ICMR National Institute for Research inTuberculosis |
| Address |
No.1, Mayor Sathyamoorthy Road, Chetput, Chennai 600 031 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| India TB Research Consortium |
Indian Council of Medical Research,
V.Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh solanki |
BJ Medical College |
Department of Pulmonary Medicine, Asarwa, Gujarat 380016
Ahmadabad
|
9825319344
rns04sec@yahoo.co.in |
| Dr Kiran Keny and Dr Lalit Anande |
Group of Tuberculosis Hospitals |
MDR-TB ward, Jerbai Wadia Rd, Sewree East, Mumbai, Maharashtra 400015
Mumbai
|
08082130181
msgtb2012@gmail.com |
| C Padmapriyadarsini and R Sridhar |
National Institute for Research in Tuberculosis and Govt. Hosptial of Thoracic Medicine |
Department of Clinical Research, No.1 Mayor Sathyamoorthy Road, Chetput, Chennai 600031
77, Chennai Theni Hwy, Tambaram Sanatoruim, Chennai, 600047
Chennai
|
044-28369500
darsni69@hotmail.com |
| Dr Vikram Vohra |
National Institute for Tuberculosis and Respiratory Diseases |
Department of Pulmonary Medicine, Sri Aurobindo Marg
New Delhi 110030
New Delhi
|
09810056922
drwvohra@gmail.com |
| Dr Anuj K Bhatnagar |
Rajan Babu Institute of Pulmonary Medicine & Tuberculosis |
Department of Chest and Tuberculosis, GTB Nagar, Kingsway Camp
Delhi 1100009
North
|
9818321353
anuuj1968@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| BJ Medical college, Ahamedabad |
Approved |
| Group of TB Hospitals, Mumbai |
Approved |
| National Institute for Research inTuberculosis AND Govt.Hopsital of Thoracic Medicine |
Approved |
| National Institute for Tuberculosis and Respiratory Diseases |
Approved |
| Rajan Babu Institute of Pulmonary Medicine and Tuberculosis |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tuberculosis of lung |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Bedaquiline, Delmanaid, Linezolid, Clofazimine |
24 -36 weeks (6-9 months): Bedaquiline (400mg) daily orally for 2 weeks followed by 200 mg thrice weekly for 22 weeks, Delamanid (100mg) twice daily oral for 24 weeks, Linezolid (600mg) daily orally for 24 weeks and Clofazimine (200mg) daily for 24 weeks to be taken orally |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Men or women aged 18 years and above
2.Multiple Drug Resistant TB documented by culture positive sputum for Mycobacterium tuberculosis with documented resistance to Rifampicin, with or without Isoniazid, AND Fluoroquinolone or a second line injectable (Pre-XDR) OR both Fluoroquinolone and a second line injectable (XDR)
3.A minimum of two positive sputum smears for acid-fast bacilli or at least one culture positive with negative sputum smears from specimens collected no more than 6-weeks
4.Chest X-Ray results consistent with pulmonary TB along with points 2 & 3
5.Body weight of ≥30 kg
6.Willingness and ability to attend scheduled follow-up visits and undergo study assessments
7.Provide written informed consent
8.Provide consent to HIV testing (
9.If male or female participant of childbearing potential, willingness to use effective methods of birth control
|
|
| ExclusionCriteria |
| Details |
1.Unstable disease i.e uncontrolled diabetes,cardiomyopathy,extra pulmonary TB,significant cardiac arrhythmias.
2.Current Hepatitis B & C, HIV, alcohol, barbiturates,amphetamine,narcotic use.
3.History of previous treatment with Bedaquiline or Delamanid.
4.Females with positive pregnancy test at screening or planning to conceive during study or within 6 months of cessation of drugs.Males planning to conceive during study or within 6 months of cessation of drugs.
5.Study participants with abnormal liver function test,hemogram,creatinine laboratory values.
6. Grade II peripheral newuropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cure rate at end of treatment with study regimen |
6-9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of bacteriological relapse during 48 weeks post treatment follow-up.
2.Incidence of bacteriological failure or clinical failure during treatment period.
3.Treatment Emergent Adverse events of any type at any time while on combination treatment regimen,Discontinuation of study drugs for any reason,Death.
4.Time to sputum culture conversion from positive to negative in the liquid/LJ culture system. |
6-9 months |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
NONE YET |
|
Brief Summary
|
Currently treatment for drug resistant pulmonary TB is long-drawan (18-20 months) with an injectable and many toxic drugs. Inspite of this the cure rate is low and the default rates are high either dur to the long drawn treatment course or due to drug toxicity. With the availability of two new drugs, bedaquiline and delmanid with a new mechanism of action, there is an opportunity now to combine these drugs and plan a shorter and less toxic regimen for the management of these patients. Hence we propose to evaluate the efficacy of a new fully oral non-injectable treatment regimen of 6-9 months duration consisting of Bedaquiline (BDQ), Delamanid (DLM), Linezolid (LZD) and Clofazimine (CFZ) in adult patients with pre-extensive (pre-XDR) or extensively drug resistant (XDR) pulmonary tuberculosis. The study will also evaluate the safety and tolerability of this treatment regimen and also determine the time to sputum culture conversion with this combination treatment regimen. We will also determine the steady state blood levels of the new study drugs and their metabolites. This is a multi-centric study being planned in 5 sites of the country ver a period of 3 years. |
