Study on Tuberculosis resistant to treatment

Active, not recruiting

Conditions: Tuberculosis of lung,

Registration Number: CTRI/2019/01/017310

Lead Sponsor: ICMR National Institute for Research inTuberculosis

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 165

Inclusion Criteria

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 â‰¥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.

Exclusion Criteria

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.
Grade II peripheral newuropathy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate at end of treatment with study regimen	6-9 months

Secondary Outcome Measures

Name	Time	Method
1.Incidence of bacteriological relapse during 48 weeks post treatment follow-up.	2.Incidence of bacteriological failure or clinical failure during treatment period.

Trial Locations

Locations (5): BJ Medical College
🇮🇳
Ahmadabad, GUJARAT, India
Group of Tuberculosis Hospitals
🇮🇳
Mumbai, MAHARASHTRA, India
National Institute for Research in Tuberculosis and Govt. Hosptial of Thoracic Medicine
🇮🇳
Chennai, TAMIL NADU, India
National Institute for Tuberculosis and Respiratory Diseases
🇮🇳
Delhi, DELHI, India
Rajan Babu Institute of Pulmonary Medicine & Tuberculosis
🇮🇳
North, DELHI, India
BJ Medical College
🇮🇳Ahmadabad, GUJARAT, India
Dr Rajesh solanki
Principal investigator
9825319344
rns04sec@yahoo.co.in