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Cost-effectiveness, utilization pattern and adverse effect of anti-tuberculosis medicines (Bedaquiline and Delamanid) in children and adolescent multi drug-resistant patients.

Cost-effectiveness, drug utilization study and safety of bedaquiline and delamanid based regimen in pediatric and adolescent MDR-TB patients in a tertiary care hospital. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/073225
Enrollment
100
Registered
2024-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: Z870- Personal history of diseases of the respiratory system

Interventions

Intervention1: NIL: NIL

Sponsors

Patel Jaykumar Rameshbhai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Data of confirmed cases of MDR- TB admitted in the respiratory medicine department.

Exclusion criteria

Exclusion criteria: a)Case Records with inadequate details b)Drug resistant TB with people with antiretroviral therapy (ART) c)Patients below age of 6 years.

Design outcomes

Primary

MeasureTime frame
1. To study the pharmaco-economic variables (cost effectiveness, cost minimization, cost-utility and cost-benefit) 2. Evaluation of prescription for DUS by WHO prescribing core indicators. 3. Assessment of causality, preventability and severity of adverse drug reactions (ADRs). • Causality assessment of ADRs by using WHO-UMC criteria • Severity Assessment by using Modified Hartwig & Siegel Scale • Preventability of ADRs by using Modified Schumock & Thornton Scale Timepoint: 1 Year

Secondary

MeasureTime frame
To find the correlation of demographic data like socioeconomic status, area, gender and resistance pattern of anti-TB drugsTimepoint: 1 Year

Countries

India

Contacts

Public ContactPatel Jaykumar Rameshbhai

Government Medical College, Surat

drchetnapatel2012@yahoo.com7990618600

Outcome results

None listed

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