Tuberculosis
Conditions
Interventions
Amikacin and Bedaquiline
Standard of Care
Sponsors
Institute of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants 14 years and older (age at which Pa can be used). • Able and willing to provide written informed consent and assent if applicable. • Participants must be able to comply with the procedures defined for the study. • Participants must agree to start treatment at the study site. • Women of childbearing potential (i.e. not surgically sterilized, experienced menarche and pre-menopausal) should have a negative pregnancy test at screening. • People diagnosed with Rr-TB who either: - Returned to care after being LTFU from receiving a Rr-TB regimen containing BDQ, and without proof of bacteriological conversion during their previous treatment, or - Met the criteria of bacteriological failure while being on Rr-TB treatment containing BDQ, or - Relapsed after successfully completing a Rr-TB regimen containing BDQ, or - Have a DST result confirming BDQ resistance, regardless of previous treatment history for Rr-TB.
Exclusion criteria
Exclusion criteria: • Participants with extrapulmonary TB and without pulmonary involvement of TB, as response to treatment cannot be monitored bacteriologically for such form of TB; • Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the participant or prevent, limit, or confound protocol specified procedures; • Ongoing pregnancy or breast feeding at screening; • Being on treatment for presumptive or confirmed BDQ resistance for > 14 days. • Having participated in other clinical trials with investigational agents within 8 weeks prior to screening or currently enrolled in another clinical trial on BDQr/Rr-TB; • The participant moves out of the catchment area of the study site. • At the start of the BacTR regimen, unavailability of drugs to constitute the regimen recommended by the treatment recommender/expert panel.to constitute the regimen recommended by the treatment recommender/expert panel. Participants becoming pregnant during the BacTR trial will remain in the trial, and their treatment regimen will be adapted with advice of the clinical expert panel. This is coherent with approaches in other Rr-TB trials (33). Similar approach will be applied for participants with an AE and requiring an adaptation of their regimen).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary objective is to estimate the proportion of participants with end-of-treatment success and to determine whether this proportion exceeds 50% among those treated within the BacTR. A multi-category variable will be defined at end-of-treatment which can take the following results. (a) Cure (b) Treatment completed (c) Bacteriological Failure (d) Lost to follow up (e) Death (f) Reinfection (g) No outcome/withdrawal This multi-category outcome at end-of-treatment will be dichotomized as either favourable, or unfavourable, or missing in case the outcome could not be derived. - Favourable is defined as either cure or treatment completed - Unfavourable is defined as either death or bacteriological failure - Missing is defined as LTFU, withdrawal, or proof of reinfection with a different strain than the baseline one The resulting binary variable will be the primary outcome used to estimate the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To summarize regimen safety (SEA, grade 3 or higher AEs probably or definitively related to TB drugs used, AEs of specific interest), overall, and by subgroup (with/without highly bactericidal empirical phase & by country) Outcomes for secondary objective: - Multiple safety related variables will be created related to - Having an SAE - Having an AE of grade 3 or higher related to treatment - Having an AESI of specific types, as defined in section 2 - Having an AESI of grade 3 or higher - Time to AE related to treatment/AESI of grade 3 or higher | — |
Countries
South Africa
Contacts
Public ContactNicole Audrey Glover
Country Co PI Investigator and Project Coordinator
Outcome results
None listed