CompletedNot Applicable

Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition (TB-Speed SAM)

Uganda, Zambia603 participantsStarted 2019-11-04

Plain-language 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).

Who can participate

Age range2 Months – 59 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 2 to 59 months * Severe acute malnutrition defined as weight-for-height Z score (WHZ) \< -3 standard deviation (SD) or mid-upper arm circumference (MUAC) \< 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema * Hospitalized per hospital clinician's decision * Parent/guardian informed consent Exclusion Criteria: \- Ongoing TB treatment or history of intake of anti-TB drugs in the last 3 months

What they're measuring

Sensitivity of the score obtained

Timeframe: 6 months

Specificity of the score obtained

Timeframe: 6 months

Trial details

NCT IDNCT04240990

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-20

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