Visit | Screening | Baseline visita | Treatment | Â | Â | Â | Â | Â | Â | Â |
---|---|---|---|---|---|---|---|---|---|---|
Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Weeks (w) | −2 w to −1 d | 0 | 1 w | 2 w | 4 w | 8 w | 12 w | 16 w | 20 w | 24 w |
Visit window | NA | NA | ±4 d | ±4 d | ±1 w | ±2 w | ±2 w | ±2 w | ±2 w | ±2 w |
Consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | Â | X | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Physical examination | X | Â | X | X | X | X | X | X | X | X |
Neurologic examination | X | Â | X | X | X | X | X | X | X | X |
Xpert MTB/RIF® assay | X |  |  |  |  |  |  |  |  |  |
Sputum AFB smear | X | Xd | X | X | X | X | X | X | X | X |
TB culture (solid) | X | Xd | X | X | X | X | X | X | X | X |
TB culture (liquid) | X | Xd | X | X | X | X | X | X | X | X |
DSTb | With first cultured Mycobacterium tuberculosis | |||||||||
CXR | X | Xd | Â | Â | X | X | X | X | X | X |
HIV, HBV | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Total bilirubin, AST/ALT, creatinine | X | Xd | X | X | X | X | X | X | X | X |
Complete blood count | X | Xd | X | X | X | X | X | X | X | X |
Optic test | Â | X | X | X | X | X | Â | Â | Â | Â |
Urine HCGc | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Compliance of drug intake | Â | Â | X | X | X | X | X | X | X | X |
Adverse drug reaction | Â | Â | X | X | X | X | X | X | X | X |
Other medicationse | Â | X | X | X | X | X | X | X | X | X |