Observation/Investigation | Screening | Treatment Phase (weeks) | Follow-up (Post-treatment phase, months) | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Study visits | 0 | 2 | 4 | 6 | 8 | 12 | 16 | 19 | 22 | 26 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | |
Time window (days) | ±3 | ±3 | ±3 | ±3 | ±7 | ±7 | ±7 | ±7 | ±7 | ±14 | ±14 | ±14 | ±14 | ±14 | ±14 | ±14 | ±14 | ||
Demographics | X | ||||||||||||||||||
Written or witnessed informed consent | X | ||||||||||||||||||
Patients eligible criteria judgement | X | ||||||||||||||||||
Medical history and clinical assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Concomitant diseases and medication taken assessment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Randomized assignment | X | ||||||||||||||||||
Efficacy evaluation | |||||||||||||||||||
Bacteriological test | Sputum smear | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Sputum culture | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
X-ray | X | X | X | X | X | X | X | X | |||||||||||
Safety evaluation | |||||||||||||||||||
Complete blood count | X | X | X | X | X | X | X | X | |||||||||||
Urinalysis | X | X | X | X | X | X | X | X | |||||||||||
Hepatic and renal functions | X | X | X | X | X | X | X | X | |||||||||||
Electrocardiograph (ECG) | X | X | X | X | X | X | X | X | |||||||||||
Body weight | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Adverse effect record | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Others | |||||||||||||||||||
Drug distribution log | X | X | X | X | X | X | X | X | X | ||||||||||
Drug retrieve log | X | X | X | X | X | X | X | X | X |