FindTrial
Sign In

Pharmacokinetics of second line anti tuberculosis drugs in Children and Adolescents with Drug Resistant Tuberculosis

Determination of Pharmacokinetics and Antimycobacterial Activity of Bedaqualine, Delamanid, Clofazimine and Linezolid in Children and Adolescents with Drug Resistant Tuberculosis - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088801
Enrollment
100
Registered
2025-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: A188- Tuberculosis of other specified organs

Interventions

Intervention1: Nil: Nil

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with drug resistant TB Receiving ATT regimen (for DR-TB) as prescribed by the treating paediatrician regularly for at least four weeks Should receive at least 3 drugs from Bedaqualine, Delamanid, Clofazimine, Linezolid

Exclusion criteria

Exclusion criteria: Caregivers / parents unwilling for hospitalisation and blood sampling

Design outcomes

Primary

MeasureTime frame
To determine the highest AUC for Bedaqualine, Delamanid, Clofazimine,and Linezolid that is both safe and tolerable. Timepoint: at baseline—

Secondary

MeasureTime frame
Determine the proportion of children with adverse drug reactions to Bedaqualine, Delamanid, Clofazimine, & Linezolid To identify factors associated with poor outcomes in children with DR-TB.Timepoint: baseline—

Countries

India

Contacts

Public ContactDr Aishwarya Venkataraman

ICMR-NIRT

venkataraman.a@icmr.gov.in00914428369500

Outcome results

None listed

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