Newly diagnosed and untreated sputum smear positive tuberculosis patient
Pulmonary lesion consistent with TB by radiological examination
Positive sputum culture, identification of bacterial type confirmed Mycobacterium tuberculosis. MGIT drug sensitivity test (DST) results are sensitive of the first-line drugs (isoniazid, streptomycin, rifampicin and ethambutol).
Age 18 years-65 years old
Males or non-pregnant, non-nursing females
Serum or plasma aminotransferases (AST, ALT) less than 3 times the upper limit of normal
Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal
Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal
Serum or plasma potassium level greater than or equal to 3.5 meq/L
Hemoglobin level of 7.0 g/dL or greater
Platelet count of 100,000/mm3 or greater
For women of childbearing potential, a negative pregnancy test is required during screening
Provides written informed consent
Willingness and ability to attend scheduled follow-up visits and undergo study assessments.

NCT03561753_inc_T1
Qualifier
untreated
NCT03561753_inc_T2
Qualifier
Newly diagnosed
NCT03561753_inc_T3
Measurement
sputum smear
NCT03561753_inc_T4
Value
positive
NCT03561753_inc_T5
Condition
tuberculosis
NCT03561753_inc_T6
Scope
Newly diagnosed and untreated
NCT03561753_inc_T7
Condition
Pulmonary lesion
NCT03561753_inc_T8
Condition
TB
NCT03561753_inc_T9
Procedure
radiological examination
NCT03561753_inc_T10
Qualifier
consistent with TB
NCT03561753_inc_T11
Value
Positive
NCT03561753_inc_T12
Measurement
sputum culture
NCT03561753_inc_T13
Condition
Mycobacterium tuberculosis
NCT03561753_inc_T14
Qualifier
bacterial type
NCT03561753_inc_T15
Measurement
MGIT drug sensitivity test (DST)
NCT03561753_inc_T16
Value
sensitive of the first-line drugs (isoniazid, streptomycin, rifampicin and ethambutol)
NCT03561753_inc_T17
Drug
first-line drugs
NCT03561753_inc_T18
Drug
isoniazid
NCT03561753_inc_T19
Drug
streptomycin
NCT03561753_inc_T20
Drug
rifampicin
NCT03561753_inc_T21
Drug
ethambutol
NCT03561753_inc_T22
Scope
isoniazid, streptomycin, rifampicin and ethambutol
NCT03561753_inc_T23
Person
Age
NCT03561753_inc_T24
Value
18 years-65 years old
NCT03561753_inc_T25
Person
Males
NCT03561753_inc_T26
Negation
non-
NCT03561753_inc_T27
Condition
pregnant
NCT03561753_inc_T28
Negation
non-
NCT03561753_inc_T29
Observation
nursing
NCT03561753_inc_T30
Person
females
NCT03561753_inc_T31
Scope
non-pregnant, non-nursing females
NCT03561753_inc_T32
Measurement
plasma aminotransferases
NCT03561753_inc_T33
Measurement
AST
NCT03561753_inc_T34
Measurement
ALT
NCT03561753_inc_T35
Measurement
 or  transferases (AST
NCT03561753_inc_T36
Scope
Serum or plasma aminotransferases
NCT03561753_inc_T37
Scope
AST, ALT
NCT03561753_inc_T38
Value
less than 3 times the upper limit of normal
NCT03561753_inc_T39
Qualifier
plasma
NCT03561753_inc_T40
Qualifier
Serum
NCT03561753_inc_T41
Measurement
total bilirubin
NCT03561753_inc_T42
Value
less than or equal to 2.5 times the upper limit of normal
NCT03561753_inc_T43
Scope
Serum or plasma
NCT03561753_inc_T44
Qualifier
plasma
NCT03561753_inc_T45
Qualifier
Serum
NCT03561753_inc_T46
Measurement
creatinine level
NCT03561753_inc_T47
Value
less than or equal to 2 times the upper limit of normal
NCT03561753_inc_T48
Scope
Serum or plasma
NCT03561753_inc_T49
Qualifier
Serum
NCT03561753_inc_T50
Qualifier
plasma
NCT03561753_inc_T51
Measurement
potassium level
NCT03561753_inc_T52
Value
greater than or equal to 3.5 meq/L
NCT03561753_inc_T53
Scope
Serum or plasma
NCT03561753_inc_T54
Measurement
Hemoglobin level
NCT03561753_inc_T55
Value
7.0 g/dL or greater
NCT03561753_inc_T56
Measurement
Platelet count
NCT03561753_inc_T57
Value
100,000/mm3 or greater
NCT03561753_inc_T58
Person
women
NCT03561753_inc_T59
Observation
childbearing potential
NCT03561753_inc_T60
Value
negative
NCT03561753_inc_T61
Measurement
pregnancy test
NCT03561753_inc_T62
Scope
women of childbearing potential
NCT03561753_inc_T63
Temporal
during screening
NCT03561753_inc_T64
Reference_point
screening
NCT03561753_inc_T65
Observation
written informed consent
NCT03561753_inc_T66
Observation
ability to attend scheduled follow-up visits
NCT03561753_inc_T67
Observation
tend sched  assessments
NCT03561753_inc_T68
Observation
eduled follow-up visits and undergo nd ability
NCT03561753_inc_T69
Observation
ed  assessments nd ability