Table 2.
Visit | Screening | Baseline visita | Treatment | |||||||
---|---|---|---|---|---|---|---|---|---|---|
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 | |||||||||
Randomization | X | |||||||||
Medical history | X | |||||||||
Physical examination | X | X | X | X | X | X | X | X | X | |
Neurologic examination | X | 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 | X | X | X | X | X | X | ||
HIV, HBV | X | |||||||||
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 | X | X | X | X | X | |||||
Urine HCGc | X | |||||||||
Compliance of drug intake | X | X | X | X | X | X | X | X | ||
Adverse drug reaction | X | X | X | X | X | X | X | X | ||
Other medicationse | X | X | X | X | X | X | X | X | X |
w weeks, d days, NA not applicable, AFB acid-fast bacilli, TB tuberculosis, DST drug susceptibility test, CXR simple chest radiography, HIV human immunodeficiency virus, HBV hepatitis B virus, AST aspartate transaminase, ALT alanine transaminase, HCG human chorionic gonadotropin
aTreatment will be initiated at the baseline visit, as TB treatment should be started promptly following diagnosis
bDrug susceptibility test for isoniazid, rifampicin, ethambutol, pyrazinamide, streptomycin, kanamycin, amikacin, capreomycin, ofloxacin, levofloxacin, moxifloxacin, prothionamide, cycloserine, and para-aminosalicylic acid
cOnly in females of childbearing potential
dCan be omitted if the results of previous tests within the prior 4 weeks are available
eIn particular, immunosuppressive agents (including corticosteroids)