Tuberculosis
Conditions
Interventions
Standardised 5 to 9 months treatment regimen described below.
Six months standard of care BPaLM treatment regimen.
Sponsors
Damian Foundation Niger
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have bacteriologically or molecularly confirmed tuberculosis with evidence of resistance to at least rifampicin and susceptibility to fluoroquinolones. 2. Be willing and able to give informed consent to be recruited into the research and follow-up project (consent signed or witnessed if illiterate).
Exclusion criteria
Exclusion criteria: 1. Have taken second-line drugs included in the treatment regimen for more than one month in the past. 2. Patients with baseline FQ resistance 3. Patients with baseline SLI resistance 4. Diabetic patients 5. Any abnormalities in basal audiometry and renal function, thus contra-indication for SLI 6. Have a QTcF interval = 500 msec at baseline and not corrected by medical management. 7. Have any other medical contraindication to taking the study schematics. 8. Children 14 years old or younger 9. Pregnant and breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to compare safety (defined as the absence of severe adverse events (grade 3-5) probably or definitively related to anti-TB drugs up to 6 months after the end of treatment) between a modified 5-month treatment regimen without linezolid and the BPaLM regimen for the treatment of fluoroquinolone-susceptible RR-TB. We aimed at being specific, focusing on anti-TB drug related adverse events, while aiming at remaining sensitive and considering “any grade 3-5 adverse event probably or definitively related to anti-TB drug up to 6 months after the end of treatment.” •“any grade 3-5 adverse event” If we would spell out the type of adverse event known to occur with linezolid and injectable drugs, we might overlook other less frequent adverse events. Moreover, we are comparing regimens, not drugs. •“probably or definitively related to anti-TB drug: if we would use “any grade 3-5 adverse event” the difference between both regimens, if any, might be missed, as it would be less specifically measuring the effect of TB drugs. •“up to 6 months after the end of treatment”: some adverse events may worsen after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the correlation between the occurrence of severe adverse events (grades 3-5) probably or definitively related to linezolid and BMI, body surface area, serum linezolid concentration, creatinine clearance in the BPaL(M) regimen. 2. To describe the efficacy (assessed by "therapeutic success" being defined as "cure" or "completed treatment" with no relapses 12 months after the end of treatment) of the two regimens (5 months without linezolid vs. BPaL(M)) 3. To evaluate the prevention of acquired resistance (defined as acquired resistance to bedaquiline and/or levofloxacin following treatment failure or relapse) of the two regimens (5 months without linezolid vs. BPaL(M)) 4. Determine the feasibility (as assessed by treatment adherence, measured by the proportion of patients who took at least 90% of doses of a short 6-month linezolid-free regimen compared with the 6BPaL(M) regimen. 5. To describe treatment outcomes in detail, by regimen, and determine the proportion of RR-TB patients treated with the regimens studied who experienced: treatment failure, death during treatment, loss of follow-up during treatment, relapsed during the 12-month follow-up period, had RR-TB reinfection during the 12-month follow-up period. 6. Describe above mentioned safety end treatment outcomes in patients excluded from the cluster randomization, but still eligible to be treated with one of both study regimens. | — |
Countries
Niger
Contacts
Public ContactAlphazazi Soumana
National Tuberculosis Program Coordinator
Outcome results
None listed