Multidrug- and rifampicin-resistant tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
A stepped-wedge design comparing patients receiving the new all-oral shorter MDR/RR-TB regimen (i.e. bedaquiline + linezolid) and patients receiving the standard all-oral MDR/RR-TB short treatment reg
then substitute with moxifloxacin (if found sensitive)
The total duration of treatment is 11 months and the duration of follow-up is 12 months after completion of treatment.
Sponsors
World Health Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population includes TB patients with evidence of resistance to at least rifampicin by rapid molecular drug-susceptibility testing (DST). 1. =15 years of age; is willing and able to give informed consent to be enrolled in the research project and for follow-up (signed or witnessed consent if the patient is illiterate) 2. Has bacteriologically or molecularly confirmed TB with evidence of resistance to at least rifampicin 3. Has no resistance to fluoroquinolones; no known previous exposure (of > 1 month) or intolerance to one or more second-line drugs in the shorter MDR-TB regimen
Exclusion criteria
Exclusion criteria: 1. DST showing infection with a strain resistant to fluoroquinolones (or DST results not available) 2. Previous exposure to or intolerance to second-line anti-TB drugs in the intended shorter MDR-TB regimen for more than 1 month 3. Pulmonary TB that is clinically severe, or advanced (i.e. parenchymal lesions) or disseminated 4. Unable to take oral medication, or to attend or comply with treatment or follow-up schedule 5. Taking medication contraindicated with the medicines in the RR/MDRTB regimen 6. Known insufficient function of heart (QTcF >500 ms), liver (ALT/AST >5x UNL), or kidneys (creatinine >2x UNL or creatinine clearance <50 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment effectiveness: the proportion of MDR-TB patients who have a favorable treatment outcome. This is defined as 'cured' or 'treatment completed' without recurrence during 12 months after successful treatment. 2. Treatment safety: the proportion of MDR-TB patients included in the study with serious adverse events occurring during treatment and up to12 months after the end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of MDR-TB patients who died while on treatment, recorded using DR-TB 01 patient data collection form, during 11 months of treatment 2. The proportion of MDR-TB patients who had a treatment failure, recorded using DR-TB 01 patient data collection form, at 12 months after successful treatment 3. The proportion of MDR-TB patients who had a recurrent episode of MDR-TB, recorded using DR-TB 01 patient data collection form, at 12 months after successful treatment 4. The proportion of MDR-TB patients who are “cured without permanent disability”, recorded using DR-TB 01 patient data collection form, at 12 months after successful treatment 5. The proportion of MDR-TB patients who complete at least 90% of doses (intake adherence, recorded using DR-TB 01 patient data collection form, during 11 months of treatment 6. The average number of adverse events of interest experienced by MDR-TB patients, recorded using DR-TB 01 patient data collection form, during 11 months of treatment 7. The proportion of MDR-TB patients experiencing each adverse event of interest, recorded using DR-TB 01 patient data collection form, during 11 months of treatment 8. The proportion of MDR-TB patients who experience serious adverse drug reactions, recorded using DR-TB 01 patient data collection form, during 11 months of treatment 9. Health-related quality of life measured using EQ-5DL at baseline, at treatment completion, 4 months of treatment intake, at treatment completion and 12 months after treatment completion 10. Feasibility assessed using mixed-method indicators at treatment completion | — |
Countries
Pakistan
Outcome results
None listed