Table 1 Inclusion and exclusion criteria for study enrolment
Inclusion criteria | Exclusion criteria |
|---|---|
Children 0–13 years, > 2.5 kg, living with or without HIV | Extra-thoracic TB only TB treatment for > 2 days in previous 2 weeks Alternative diagnosis at baseline Severe illness resulting in unstable clinical condition |
Written informed consent from the parent or legal guardian | Informed consent not obtained Contra-indication to sampling procedures Discharge before baseline sampling completed Unstable social circumstances Residence in remote areas |
Presumed pulmonary TB, inpatient or outpatient, identified in hospital with ≥ 1 of: 1. Persistent unremitting cough or wheezing of > 2 weeks, unresponsive to a course of antibiotics 2. Poor growth over the preceding 3 months 3. Persistent unexplained lethargy or reduced playfulness/activity > 2 weeks 4. Persistent unexplained fever > 1 week 5. Neonatal pneumonia, hepatosplenomegaly, or sepsis-like illness, unexplained and unresponsive to appropriate treatment 6. Any duration of cough, wheeze or acute pneumonia with ≥ 1: a. Close infectious TB contact OR b. Reactive tuberculin skin test OR c. Chest radiograph suggestive of TB 7. Recurrent (≥ 1 episode per month) respiratory symptoms |