At a glance
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Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition
In Brief
A clinical study evaluating Development of a score and algorithm for TB treatment decision in hospitalised children with SAM. for Tuberculosis and Severe Acute Malnutrition. Completed, enrolled 603 participants across 3 sites in 2 countries.
Detailed Summary
TB-Speed SAM is a multicentric, prospective diagnostic cohort study conducted in two countries with high and very high TB incidence (Uganda and Zambia). It aims at assessing several diagnostic tests that could result in the development of a score and algorithm for TB treatment decision in hospitalised children with severe acute malnutrition (SAM).
Study Details
Timeline
Interventions
The diagnostic strategy will include an initial clinical, radiographic and bacteriological evaluation of all enrolled children: * TB contact history * Suggestive TB symptoms in the previous 4 weeks * Physical examination * Clinical, anthropometric and biochemical assessment of malnutrition * Clinical assessment for other non-dietary causes of malnutrition * Digitalized CXR * Ultra performed on NPA and stool samples, and one gastric aspirate (GA) * Mycobacterial culture performed on two GAs * Abdominal ultrasonography * QuantiFERON®-TB Gold IGRA * Monocyte-to-Lymphocyte Ratio (MLR) * C-Reactive Protein (CRP) TB diagnosis will be made according to national TB guidelines.