Health Condition 1: A157- Primary respiratory tuberculosis
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Bhagat Phool Singh Government Medcal College for Women
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with age 14 years and above with microbiologically confirmed Drug-Resistant Tuberculosis (Rifampicin Resistant Tuberculosis/ Multi-drug Resistance Tuberculosis/ Extensive Drug Resistance Tuberculosis). 2.Subjects who are willing to give written informed consent (assent where applicable). 3.H/o of Drug Exposure: Person with exposure of less than one month intake of Bedaquiline, Pretomanid and/ or Linezolid in the past. or Person with exposure of more than one month intake of Bedaquiline, Pretomanid and/ or Linezolid and documented sensitivity to these drugs. or Person who had not failed treatment with Bedaquiline or Linezolid containing shorter or longer regimen, and sensitivity to these drugs is documented.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Parameters - Final Treatment Outcome, Sputum Culture Conversion, Time to Culture Conversion Safety Parameters - Type of ADRs, Frequency of ADRs, Severity of ADRsTimepoint: Efficacy Parameters - Weeks 8, 12, 16, 20 and 26(End of Treatment) Safety Assessment - Weeks 2, 4, 8, 12, 16, 20, and 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence Parameters Missed Doses, Default Episodes, Reasons for Missed Doses Quality of Life Parameters - Physical Health, Psychological Health, Social Relationships, EnvironmentTimepoint: Adherence Assessment - Weeks 2, 4, 8, 12, 16, 20, and 26 Quality of Life Assessment On Enrolment and End of Treatment (Week 26) | — |
Countries
India
Contacts
Public ContactMayank Singh Shekhawat
B. P. S. Government Medical College For Women
Outcome results
None listed