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

NCT04240990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2025-12-10

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

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

    lead OTHER_GOV

Principal Investigators

  • Olivier Marcy, MD, PhD · University of Bordeaux, France

  • Maryline Bonnet, MD, PhD · Institut de Recherche pour le Développemnt (IRD) Montpellier, France

  • Eric Wobudeya, MD, PhD · MU-JHU Care Ltd, Kampala, Uganda

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • Uganda
  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240990 on ClinicalTrials.gov