Efficacy of ultra-short course chemotherapy for new smear positive drug susceptible pulmonary tuberculosis: study protocol of a multicenter randomized controlled clinical trial

Table 3 Assessment schedule – for all patients recruited

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
Bacteriological test	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

ISSN: 1471-2334