use of Bedaquiline and Delamanid in TB patients

Safety and Tolerability of Bedaquiline and Delamanid along with Optimized Background Regimen for treatment of Paediatric DRTB (RR/ MDR/ Pre XDR/ XDR TB) in children aged 6-18 Years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042659

Enrollment

220

Registered

2022-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A159- Respiratory tuberculosis unspecified

Interventions

Intervention1: NIL: NIL Intervention2: Bedaquiline drug upto 24 weeks time period: Cohort 1/2/3 Intensive phase (6-8) (Dlm/Bdq/ SLI) Mfxh Lzd Cfz Cs Continuation Phase 12 Lfx/Mfxh Lzd (l) Cfz Cs Lfx c

Eligibility

Inclusion criteria

Inclusion criteria: Subject must be a boy or girl, aged from birth (6 -18 years) at screening. Subject must be confirmed (RR/MDR /PreXDR/XDR TB) or probable MDR TB. CXR consistent with intrathoracic TB disease (eg, fibrocavitory disease and infiltrations, miliary TB, pleural effusion, fibrotic pleural lesions, intrathoracic lymphadenopathy) and confirmed or probable pulmonary MDR-TB, including pre-extensively drug-resistant TB (pre-XDR-TB) or XDR-TB infection, based on the case definitions of pediatric pulmonary TB24 . Cases with concomittant Extra pulmonary involvement along with PTB will be classified as PTB and enrolled in the study. The parent or legal guardian of each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing for his/her ward to participate in the study.

Exclusion criteria

Exclusion criteria: 1 Pt not giving consent (gurdians) 2 Cases of EPTB without pulmonary involvement, disseminated, meningeal or central nervous system TB 3 Marked QTc interval of >500 msec or patient having significant cardiac arrhythymia or complete heart block 4 Other exclusion criteria: Intolerance to drugs being used in regimen 5 Any medical contraindication as per drug manual

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of Bedaquiline and Delamanid over a 24-week treatment with Optimized Background regimen(OBR) in 6-18 Year old paediatric confirmed or probable DR TB patients To compare the efficacy, safety and tolerability of Bedaquiline, Delamanid with second line injectables over a 24-week treatment period, and with 6-9 months of combined Bedaquiline and Delamanid regimen along with Optimized Background regimen in 6-18 Year oldTimepoint: after 3 years	—

Measure

Time frame

To evaluate the safety and tolerability of Bedaquiline and Delamanid over a 24-week treatment with Optimized Background regimen(OBR) in 6-18 Year old paediatric confirmed or probable DR TB patients To compare the efficacy, safety and tolerability of Bedaquiline, Delamanid with second line injectables over a 24-week treatment period, and with 6-9 months of combined Bedaquiline and Delamanid regimen along with Optimized Background regimen in 6-18 Year oldTimepoint: after 3 years

—

Secondary

Measure	Time frame
â?¢ To evaluate the anti-mycobacterial activity as treatment outcomes (interim and final) of newer drugs Bedaquiline and Delamanid in confirmed or probable pulmonary MDR-TB over a 24-week treatment period. â?¢ To evaluate adherence and palatability of the adult tablet formulation and the paediatric tablet formulations, as and when these become available. â?¢ To compare the long-term safety, tolerability and efficacy of Bedaquiline, Delamanid and second line injectables in combination with OBR in confirmed or probable pulmonary MDR-TB cases, over 24 months baseline including a 6 month post treatment follow-up period (preferably also in subjects who prematurely discontinue from study drug and study procedures). â?¢ Evaluate development of resistance to drugs used in the DR. â?¢ Feasibility of adopting injection free regimens for pediatric DRTB patients under programmatic conditions. Timepoint: after 3 years	—

Measure

Time frame

â?¢ To evaluate the anti-mycobacterial activity as treatment outcomes (interim and final) of newer drugs Bedaquiline and Delamanid in confirmed or probable pulmonary MDR-TB over a 24-week treatment period. â?¢ To evaluate adherence and palatability of the adult tablet formulation and the paediatric tablet formulations, as and when these become available. â?¢ To compare the long-term safety, tolerability and efficacy of Bedaquiline, Delamanid and second line injectables in combination with OBR in confirmed or probable pulmonary MDR-TB cases, over 24 months baseline including a 6 month post treatment follow-up period (preferably also in subjects who prematurely discontinue from study drug and study procedures). â?¢ Evaluate development of resistance to drugs used in the DR. â?¢ Feasibility of adopting injection free regimens for pediatric DRTB patients under programmatic conditions. Timepoint: after 3 years

—

Countries

India

Contacts

Public ContactSangeeta Sharma

National Institute of Tuberculosis and Respiratory diseases

sangeetasharma2000@gmail.com9868138871

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026