Investigation/Observation | Baseline assessment & screening | Treatment Phase (M = Month) | Post-treatment Follow-Up | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
M T 1 | M T 2 | M T 3 | M T 4 | M T 5 | M T 6 | M T 7 | M T 8 | MT 9/11 | MF 6 | MF 12 | |||
Clinical evaluation | Demographics, Medical History | X | |||||||||||
Written informed consent | X | ||||||||||||
Clinical Examination | X | X | X | X | X | X | X | X | X | X | X | X | |
Treatment adherence | X | X | X | X | X | X | X | X | X | ||||
Concomitant treatment | X | X | X | X | X | X | X | X | X | X | |||
Adverse events | X | X | X | X | X | X | X | X | X | X | |||
Bacteriology Y | Sputum smear | 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 | |
DST (FQ) | X | ||||||||||||
Laboratory tests | Hemoglobin/platelets count/White blood count | X | X | X | X | X | X | X | X | X | X | ||
Serum liver enzymes | X | X | X | X | X | X | X | X | X | X | |||
Serum creatinine (at baseline and if clinically indicated or ECG abnormalities) | X | ||||||||||||
Serum potassium (at baseline and if clinically indicated or ECG abnormalities) | X | ||||||||||||
Pregnancy test (female) | X | ||||||||||||
HIV testing | X | ||||||||||||
Other | ECG | X | Xβ | X | X | X | X | X | X | X | X | ||
Visual acuity & BPNS(Note: for patients receiving Lzd and high-dose INH/EMB) | X | (X) | (X) | (X) | (X) | (X) | (X) | (X) | (X) | (X) | |||
Chest X-ray | X | ||||||||||||
Disability assessment | X | X | X | ||||||||||
Health Related Quality of Life assessment | X | X | X | X |