. 2013 Mar;93(2):143–149. doi: 10.1016/j.tube.2013.01.003

Table 1.

Endpoint definitions.

TB case definition Endpoint #1
Any of the following numerical categories • Isolation of M. tuberculosis from any site. • Identification of M. tuberculosis by an approved molecular diagnostic technique from any site. • Histopathology diagnostic for tuberculosis disease (such as caseating granulomas) • Choroidal tubercle diagnosed by an ophthalmologist • Miliary pattern on chest X-ray in an HIV-negative infant • Clinical diagnosis of tuberculous meningitis (CSF protein >0.6 g/L and pleocytosis >50/mm³ with mononuclear cell >50%) with features of basal meningeal enhancement and hydrocephalus on head CT. • Vertebral spondylosis • A single smear/histology specimen positive for acid fast (or auramine positive) bacilli from a normally sterile body site. • One of the following: a) Two acid fast or auramine smears positive each from a separate collection morphologically consistent with mycobacteria from either sputum or gastric aspirate that are not found to be non-tuberculous mycobacteria bacteria on culture, OR b) QuantiFERON conversion from negative or indeterminate to positive, OR c) Tuberculin skin test ≥15 mm AND One of the following compatible radiographic features: a) Calcified Ghon focus, OR b) Pulmonary cavity, OR c) Hilar/mediastinal adenopathy, OR d) Pleural effusion, OR e) Airspace opacification, AND One of the following clinical manifestations: a) Cough without improvement for longer than two weeks, OR b) Weight loss of at least 10% of body weight for at least 2 months, OR c) Failure to thrive (crossing at least one entire major centile band downward) for at least 2 months, where the major centile bands are defined as <97th–90th, <90th–75th, <75th–50th, <50th–25th, <25th–10th, and <10th–3rd weight-for-age centiles.^∗

TB case definition Endpoint #1

Any of the following numerical categories

•
Isolation of M. tuberculosis from any site.
•
Identification of M. tuberculosis by an approved molecular diagnostic technique from any site.
•
Histopathology diagnostic for tuberculosis disease (such as caseating granulomas)
•
Choroidal tubercle diagnosed by an ophthalmologist
•
Miliary pattern on chest X-ray in an HIV-negative infant
•
Clinical diagnosis of tuberculous meningitis (CSF protein >0.6 g/L and pleocytosis >50/mm³ with mononuclear cell >50%) with features of basal meningeal enhancement and hydrocephalus on head CT.
•
Vertebral spondylosis
•
A single smear/histology specimen positive for acid fast (or auramine positive) bacilli from a normally sterile body site.
•
One of the following:
- a)
  Two acid fast or auramine smears positive each from a separate collection morphologically consistent with mycobacteria from either sputum or gastric aspirate that are not found to be non-tuberculous mycobacteria bacteria on culture, OR
- b)
  QuantiFERON conversion from negative or indeterminate to positive, OR
- c)
  Tuberculin skin test ≥15 mm

AND

One of the following compatible radiographic features:
- a)
  Calcified Ghon focus, OR
- b)
  Pulmonary cavity, OR
- c)
  Hilar/mediastinal adenopathy, OR
- d)
  Pleural effusion, OR
- e)
  Airspace opacification,

AND

One of the following clinical manifestations:
- a)
  Cough without improvement for longer than two weeks, OR
- b)
  Weight loss of at least 10% of body weight for at least 2 months, OR
- c)
  Failure to thrive (crossing at least one entire major centile band downward) for at least 2 months, where the major centile bands are defined as <97th–90th, <90th–75th, <75th–50th, <50th–25th, <25th–10th, and <10th–3rd weight-for-age centiles.^∗

TB case definition Endpoint #2
Any of the following numerical categories • Isolation of M. tuberculosis from any site. • Identification of M. tuberculosis by an approved molecular diagnostic technique from any site. • Histopathology diagnostic for tuberculosis disease (such as caseating granulomas) • Choroidal tubercle diagnosed by an ophthalmologist. • Miliary pattern on chest X ray in an HIV-negative infant • Clinical diagnosis of tuberculous meningitis (CSF protein >0.6 g/L and pleocytosis >50/mm³ with mononuclear cell >50%) or features of basal meningeal enhancement and hydrocephalus on head CT. • Vertebral spondylosis • A single smear/histology specimen positive for acid fast (or auramine positive) bacilli from a normally sterile body site. • One of the following: a) One acid fast or auramine smear positive morphologically consistent with mycobacteria from either sputum or gastric aspirate that are not found to be non-tuberculous mycobacteria bacteria on culture, OR b) QuantiFERON conversion from negative or indeterminate to positive, OR c) Residence in a household with an AFB smear positive member, OR d) Tuberculin skin test ≥10 mm AND One of the following compatible radiographic features: a) calcified Ghon focus, OR b) pulmonary cavity, OR c) hilar/mediastinal adenopathy, OR d) pleural effusion, OR e) airspace opacification, OR AND One of the following clinical manifestations: a) Cough without improvement for longer than two weeks, OR b) Weight loss of at least 10% of body weight for at least 2 months, OR c) Failure to thrive (crossing at least one entire major centile band downward) for at least 2 months, where the major centile bands are defined as <97th–90th, <90th–75th, <75th–50th, <50th–25th, <25th–10th, and <10th–3rd weight-for-age centiles.^∗

TB case definition Endpoint #2

Any of the following numerical categories

•
Isolation of M. tuberculosis from any site.
•
Identification of M. tuberculosis by an approved molecular diagnostic technique from any site.
•
Histopathology diagnostic for tuberculosis disease (such as caseating granulomas)
•
Choroidal tubercle diagnosed by an ophthalmologist.
•
Miliary pattern on chest X ray in an HIV-negative infant
•
Clinical diagnosis of tuberculous meningitis (CSF protein >0.6 g/L and pleocytosis >50/mm³ with mononuclear cell >50%) or features of basal meningeal enhancement and hydrocephalus on head CT.
•
Vertebral spondylosis
•
A single smear/histology specimen positive for acid fast (or auramine positive) bacilli from a normally sterile body site.
•
One of the following:
- a)
  One acid fast or auramine smear positive morphologically consistent with mycobacteria from either sputum or gastric aspirate that are not found to be non-tuberculous mycobacteria bacteria on culture, OR
- b)
  QuantiFERON conversion from negative or indeterminate to positive, OR
- c)
  Residence in a household with an AFB smear positive member, OR
- d)
  Tuberculin skin test ≥10 mm

AND

One of the following compatible radiographic features:
- a)
  calcified Ghon focus, OR
- b)
  pulmonary cavity, OR
- c)
  hilar/mediastinal adenopathy, OR
- d)
  pleural effusion, OR
- e)
  airspace opacification, OR

AND One of the following clinical manifestations:
- a)
  Cough without improvement for longer than two weeks, OR
- b)
  Weight loss of at least 10% of body weight for at least 2 months, OR
- c)
  Failure to thrive (crossing at least one entire major centile band downward) for at least 2 months, where the major centile bands are defined as <97th–90th, <90th–75th, <75th–50th, <50th–25th, <25th–10th, and <10th–3rd weight-for-age centiles.^∗

TB case definition Endpoint #3
All individuals who are placed on anti-tuberculosis therapy with the intent of treating tuberculosis regardless of whether they have met the other efficacy endpoints

^∗

Centers for Disease Control (CDC) Growth Charts (USA), developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion (2000).