Multi-drug Resistant Tuberculosis
Conditions
Brief summary
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
Detailed description
To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba
Interventions
None listed
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Inclusion criteria
1\. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.
Exclusion criteria
1. Patients with known hypersensitivity to Delamanid or any excipients of Deltyba® 2. Patients whose serum albumin \< 2.8 g/dL 3. Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine). 4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Deltyba | for 24 weeks | Mean values |
| Administration duration of Deltyba | for 24 weeks | Mean values |
| Compliance of Deltyba | for 24 weeks | percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of ADRs in special populations | at least 1 month after the final administration or premature discontinuation | Number (n) of subjects with ADRs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder |
| Incidences of AEs | at least 1 month after the final administration or premature discontinuation | Numbers (n) of subjects with AEs |
| Response rate | at 24 week (at the end of Deltyba administration) | Number (n) of treatment responders (sustained converters plus new converters), Numbers (n) of sustained converters, new converters, non-converters, and reverters |
| Observed cases of resistance to Deltyba after completing the administration (Week 24) or premature discontinuation of Deltyba, Observed cases of resistance to Deltyba after 6 months of administration or discontinuation of administration | after completing the administration (Week 24) or premature discontinuation of Deltyba | Numbers (n) of subjects who developed drug resistance as determined by drug susceptibility testing (DST) to Deltyba in subjects who resulted in positive in sputum test after termination of the administration or were reverter during the course of treatment |
| Incidences of ADRs | at least 1 month after the final administration or premature discontinuation | Percentages (%) of subjects with ADRs |
| Incidences of AEs in special populations | at least 1 month after the final administration or premature discontinuation | Percentages (%) of subjects with AEs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder |
Countries
South Korea
Outcome results
None listed