Tuberculosis
Conditions
Interventions
Oral Bedaquiline based drug resistant TB regimens
Sponsors
Institute of Human Virology Nigeria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulant children and adolescents 0-19 years of age. 2. Newly diagnosed DR-TB patients receiving less than 5 days of treatment preceding study entry 3. Patients willing to receive oral DR-TB treatment as prescribed by the physician. 4. Children and adolescents with parents/caregivers with ability to provide assent and sign the informed consent form. 5. Willing to provide sputum, stool, blood and urine samples. 6. Residing within the study state, and not planning to move within 12 months of the study period, with working phone numbers of self or caregivers.
Exclusion criteria
Exclusion criteria: 1. Participants not willing to enrol on oral DR-TB treatment. 2. Children placed under the control of courts or a government agency. 3. Participants who are pregnant or breastfeeding. 4. Participants who are unable to take oral medications. 5. Participants with any other medical condition, precluding study participation based on judgement of DR-TB clinical management team e.g contraindications to any of oral TB medicines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful or unsuccessful treatment outcomes | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative Incidence of DR-TB in study sites | — |
Countries
Nigeria
Contacts
Public ContactMiriam Bathnna
Senior Research Officer Co Investigator Institute of Human Virology Nigeria
Outcome results
None listed