Entry criteria: Any current compatible symptom irrespective of duration in a child suspected to have tuberculosis; use the clinical features for clinical diagnosis or disease classification.
Clearly define inclusion criteria for research with careful documentation of presenting symptoms, contact history, and signs. |
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1. Microbial confirmation
Definition: At least 1 positive culture (with confirmed M. tuberculosis speciation) or 1 positive WHO-endorsed NAAT (eg, XpertMTB/RIF assay) from sputum (which could be sampled from expectorated sputum, induced sputum, nasopharyngeal aspirates, gastric aspirates, string tests, or other relevant intrathoracic samples) or stool.
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2. Clinical signs/symptoms suggestive of tuberculosis
Persistent cough: persistent (>2 wk), unremitting cough. Weight loss/failure to thrive:
Unexplained weight loss: >5% reduction in weight compared with the highest weight recorded in last 3 mo OR Failure to thrive
Clear deviation from a previous growth trajectory, and/or Documented crossing of percentile lines in the preceding 3 mo, and/or Weight-for-age z score of ≤−2 in the absence of information on previous/recent growth trajectory, and/or Weight-for-height z score of ≤−2 in the absence of information on previous/recent growth trajectory AND
Not responding to nutritional rehabilitation (or antiretroviral therapy if HIV infected)
Persistent unexplained fever: Persistent (>1 wk) and unexplained fever (>38°C) reported by a guardian or objectively recorded at least once. Persistent, unexplained lethargy or reduced playfulness: persistent, unexplained lethargy or decrease in playfulness/activity reported by the parent/caregiver. Infants 0–60 d (or neonate): additional a signs and symptoms suggestive of tuberculosis include:
neonatal pneumoniab or unexplained hepatosplenomegalyb or sepsis-like illnessb
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3. Interpretation of CXR
CXR reading procedure
CXR (2 views) will be read by a minimum of 2 independent and blinded readers who are experienced in reviewing CXRs in children. The overall quality of the CXR will be indicated In the case of discordant overall radiological classification, a third expert reader will be used and a final consensus achieved
CXR reporting procedure
Standardized forms with predetermined terminology to describe CXR abnormalities Essential radiological features with tick boxes used by experienced readers Predetermined Yes/No options for the CXR reader
CXR is classified as “consistent with tuberculosis” if there is a positive response for any one of the radiographic features, at the same location, by at least 2 expert reviewers.
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4. Tuberculosis exposure
History of exposure to M. tuberculosis: Reported exposure to a case of tuberculosis (household/close contact) within the preceding 12 mo:
- Documented (smear positive and/or culture positive, or tuberculosis treatment) OR - Not documented but verbal report (smear positive and/or culture positive, or tuberculosis treatment)
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5. Immunological evidence of tuberculosis infection
A positive tuberculin skin test (using 5TU PPD or 2TU PPD RT23) defined as:
≥10 mm if HIV uninfected ≥5 mm if HIV infected or severely malnourished OR
A positive IGRA test
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6. Response to antituberculosis treatment
Follow-up: All patients should be followed after initial evaluation, regardless of the initial disease classification or decision to treat for tuberculosis. Treatment other than antituberculosis treatment (eg, antibiotics for community-acquired pneumonia) and response to such treatment should be recorded. All patients should undergo clinical assessment and data collection 2 mo after baseline or after treatment initiation for those treated with antituberculosis treatment. Note that not all children with symptoms will receive antituberculosis treatment, and follow-up at 2 mo would be a useful time (in addition to earlier assessments) to assess resolution of symptoms without antituberculosis treatment and/or clinical response to alternative therapy (if any) Additional suggested data collection time points
2 wk after baseline or after treatment initiation for those treated with antituberculosis treatment 6 mo after treatment initiation for those treated with antituberculosis treatment (or at end of antituberculosis treatment).
Appropriate antituberculosis treatment for presumed drug-susceptible tuberculosis should meet the following criteria:
Treatment with standard regimens in accordance with local or international tuberculosis treatment guidelines Satisfactory adherence proposed as 80% adherence by pill count or self-reported
Response to antituberculosis treatment should be evaluated at 2 mo after antituberculosis treatment has commenced using standardized forms with tick-box options for recording (eg, improvement or not of each clinical feature suggestive of tuberculosis disease indicated as Yes/No option), Complete resolution of presenting signs and symptoms Response to antituberculosis treatment is defined as
Response to antituberculosis therapy: clinical features suggestive of tuberculosis disease that were present at baseline have improved, and there is no new clinical feature suggestive of tuberculosis; OR No response to antituberculosis therapy: clinical features suggestive of tuberculosis disease that were present at baseline have not improved or have worsened.
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