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

NACompletedINTERVENTIONAL
Enrollment

603

Participants

Timeline

Start Date

November 4, 2019

Primary Completion Date

June 20, 2022

Study Completion Date

June 20, 2022

Conditions
TuberculosisSevere Acute Malnutrition
Interventions
OTHER

Development of a score and algorithm for TB treatment decision in hospitalised children with SAM.

"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."

Trial Locations (3)

Unknown

Mulago National Referral Hospital, Kampala

Lusaka University Teaching Hospital, Lusaka

Arthur Davidson Children Hospital, Ndola

All Listed Sponsors
collaborator

UNITAID

OTHER

lead

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

OTHER_GOV

NCT04240990 - Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition (TB-Speed SAM) | Biotech Hunter | Biotech Hunter