Tuberculosis Infections and Infestations
Conditions
Interventions
The study will enrol children <15 years with signs or symptoms suggestive of TB attending health facilities. Those meeting the inclusion criteria and consenting will be enrolled. Clinical assessment,
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
0 Years to 15 Years
Inclusion criteria
Inclusion criteria: Children 1 week and > 38°C 1.4. Persistent, unexplained lethargy or reduced playfulness 1.5. Infants 0 – 60 days: 1.5.1. Neonatal pneumonia 1.5.2. Unexplained hepatosplenomegaly 1.5.3. Sepsis-like illness or 2. Any duration of cough/wheeze/acute pneumonia plus any of the following: 2.1. Chest X-ray compatible with TB as interpreted by the treating physician 2.2. A history of contact with a TB patient in the last two years
Exclusion criteria
Exclusion criteria: Participants will be excluded if: 1. History of TB treatment in the last year 2. Parents refused to provide consent for study participation or HIV testing when the status is unknown 3. Severe illness resulting in an unstable condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of ultrasound for detecting tuberculosis is measured in terms of sensitivity, specificity, positive predictive value, and negative predictive value, by comparing interpretations of ultrasound images by two independent readers to chest X-ray findings (used as the gold standard) at baseline and 2 and 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic performance of ultrasound for detecting tuberculosis is measured in terms of sensitivity, specificity, positive predictive value, and negative predictive value, by comparing interpretations of ultrasound images by two independent external readers to the NIH classification of intrathoracic childhood TB as the reference standard at baseline and 2 and 6 months follow-up | — |
Countries
Mozambique
Contacts
Public ContactJessica Dalcuso
Outcome results
None listed