Tuberculosis resistant to any of the study drugs (isoniazid, rifampin, EMB, PZA, CFZ, Pto)
Unable to take oral medications.
History of allergy or intolerance to any of the study drugs
Serum aminotransferase (AST or ALT) 3x upper limit of normal or higher
Pregnant or nursing females, or plan to become pregnant or nurse during the study period
Males planning to conceive a child during the study or within 6 months of cessation of treatment.
Any treatment directed against active tuberculosis within 6 months preceding initiation of study drugs.
Suspected or documented tuberculosis involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis.
HIV infected
HBV infected or HCV infected (these increase the risk of TB-drug induced hepatotoxicity)
Weight less than 40.0 kg.
Known allergy or intolerance to any of the study medications.
Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any of the study drugs.
QTcF > 500 msec
Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.
Current or planned incarceration or other involuntary detention
Having participated in other clinical studies with dosing of investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational study that includes treatment with medicinal agents. Subjects who are participating in observational studies or who are in a follow up period of a trial that included drug therapy may be considered for inclusion.

NCT03561753_exc_T1
Condition
Tuberculosis
NCT03561753_exc_T2
Qualifier
resistant to
NCT03561753_exc_T3
Drug
study drugs
NCT03561753_exc_T4
Drug
isoniazid
NCT03561753_exc_T5
Drug
rifampin
NCT03561753_exc_T6
Drug
EMB
NCT03561753_exc_T7
Drug
PZA
NCT03561753_exc_T8
Drug
CFZ
NCT03561753_exc_T9
Drug
Pto
NCT03561753_exc_T10
Scope
isoniazid, rifampin, EMB, PZA, CFZ, Pto
NCT03561753_exc_T11
Observation
Unable to take oral medications
NCT03561753_exc_T12
Condition
allergy
NCT03561753_exc_T13
Observation
History
NCT03561753_exc_T14
Condition
intolerance
NCT03561753_exc_T15
Drug
study drugs
NCT03561753_exc_T16
Scope
allergy or intolerance
NCT03561753_exc_T17
Measurement
Serum aminotransferase
NCT03561753_exc_T18
Measurement
AST
NCT03561753_exc_T19
Measurement
ALT
NCT03561753_exc_T20
Scope
AST or ALT
NCT03561753_exc_T21
Scope
Serum aminotransferase (AST or ALT)
NCT03561753_exc_T22
Value
3x upper limit of normal or higher
NCT03561753_exc_T23
Condition
Pregnant
NCT03561753_exc_T24
Observation
nursing
NCT03561753_exc_T25
Person
females
NCT03561753_exc_T26
Mood
plan to
NCT03561753_exc_T27
Observation
become pregnant
NCT03561753_exc_T28
Observation
nurse
NCT03561753_exc_T29
Temporal
during the study period
NCT03561753_exc_T30
Scope
become pregnant or nurse
NCT03561753_exc_T31
Person
Males
NCT03561753_exc_T32
Mood
planning to
NCT03561753_exc_T33
Observation
conceive a child
NCT03561753_exc_T34
Temporal
during the study
NCT03561753_exc_T35
Temporal
within 6 months of cessation of treatment
NCT03561753_exc_T36
Reference_point
cessation of treatment
NCT03561753_exc_T37
Reference_point
the study
NCT03561753_exc_T38
Scope
during the study or within 6 months of cessation of treatment
NCT03561753_exc_T39
Qualifier
active
NCT03561753_exc_T40
Condition
tuberculosis
NCT03561753_exc_T41
Temporal
within 6 months preceding initiation of study drugs
NCT03561753_exc_T42
Procedure
treatment
NCT03561753_exc_T43
Condition
tuberculosis
NCT03561753_exc_T44
Qualifier
central nervous system
NCT03561753_exc_T45
Qualifier
bones
NCT03561753_exc_T46
Qualifier
joints
NCT03561753_exc_T47
Qualifier
miliary tuberculosis
NCT03561753_exc_T48
Qualifier
pericardial tuberculosis
NCT03561753_exc_T49
Scope
central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis
NCT03561753_exc_T50
Mood
documented
NCT03561753_exc_T51
Mood
Suspected
NCT03561753_exc_T52
Scope
Suspected or documented
NCT03561753_exc_T53
Condition
HIV infected
NCT03561753_exc_T54
Condition
HBV infected
NCT03561753_exc_T55
Condition
HCV infected
NCT03561753_exc_T57
Measurement
Weight
NCT03561753_exc_T58
Value
less than 40.0 kg
NCT03561753_exc_T59
Condition
allergy
NCT03561753_exc_T60
Condition
intolerance
NCT03561753_exc_T61
Drug
study medications
NCT03561753_exc_T62
Scope
allergy or intolerance
NCT03561753_exc_T63
Condition
M. tuberculosis isolate
NCT03561753_exc_T64
Qualifier
resistant to any of the study drugs
NCT03561753_exc_T65
Drug
study drugs
NCT03561753_exc_T66
Measurement
QTcF
NCT03561753_exc_T67
Value
> 500 msec
NCT03561753_exc_T69
Temporal
Current
NCT03561753_exc_T70
Mood
planned
NCT03561753_exc_T71
Observation
incarceration
NCT03561753_exc_T72
Observation
involuntary detention
NCT03561753_exc_T73
Scope
incarceration or other involuntary detention
NCT03561753_exc_T74
Scope
Current or planned
NCT03561753_exc_T75
Observation
participated in other clinical studies
NCT03561753_exc_T76
Drug
investigational agents
NCT03561753_exc_T77
Temporal
within 8 weeks prior to trial start
NCT03561753_exc_T78
Temporal
currently
NCT03561753_exc_T79
Observation
enrolled in an investigational study
NCT03561753_exc_T80
Reference_point
trial start
NCT03561753_exc_T81
Drug
medicinal agents