BEAT stands for ‘Building Evidence for Advance Treatment against Tuberculosis’. The emergence of drug resistance is a major threat to tuberculosis (TB) care and control. Extensively drug-resistant TB (XDR-TB) is a form of TB caused by M. tuberculosis that are resistant to isoniazid and rifampicin (i.e. MDR-TB) as well as any fluoroquinolone and any of the second–line anti-TB injectable drugs.
The treatment of XDR-TB consists of 24-30 months of 7-8 drugs along with an injectable for 6-9 months, all drugs given on a daily basis. Considering the complexity of the treatment of pre-XDR and XDR-TB cases, there is an urgent need to build a better, safer, less toxic, shorter and cheaper regimen to reduce patient suffering and mortality with careful evaluation.
The World Health Organization (WHO) recommends using well tolerated Bedaquiline (BDQ), Delamanid (DLM) and PA-824 anti-TB drugs for a standardized duration of 24 weeks in patients with drug-resistant tuberculosis. The scientific validity of comparing a 24-36 weeks (6-9 month) endpoint with a 24-27 month endpoint (standard of care) would represent a significant challenge.
This study evaluate the efficacy of a new 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.
CDSA is responsible to verify the authenticity, accuracy, and completeness of the data through routine monitoring in all the identified five clinical sites. Also, ensure Safety and rights of patient are being protected and the study is being conducted in accordance with the currently approved protocol and all applicable regulatory requirements.
|Study Title:||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
|1. National Institute for Research in Tuberculosis and Govt. Hospital of Thoracic Medicine, Chennai
2. National Institute for Tuberculosis and Respiratory Diseases, Delhi
3. Rajan Babu Institute of Pulmonary Medicine & Tuberculosis, Delhi
4. BJ Medical College, Ahmedabad
5. Group of Tuberculosis Hospitals, Mumbai
|Study Details:||• Study is in its site preparedness phase.
• Regulatory approval from DCGI dated 18 Mar 2019 and IEC approvals of all the sites are in place.
• Investigational Products have been imported.
• Study staff hiring and Protocol and GCP training are in process.