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

NCT04240990 | Completed DMC

• 1 other identifier: C18-28
• Study Type: interventional
• Target: 603
• Locations: 2 countries
• Sites: 3

Brief 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

Tuberculosis; Severe Acute Malnutrition

Keywords

Tuberculosis; Child; Malnutrition; Diagnosis; Screening

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the score obtained

  Sensitivity of the score obtained using predicted probability cut-off with the prediction model for the diagnosis of TB, defined as either confirmed or unconfirmed using the updated Clinical Case Definition for Classification of Intrathoracic Tuberculosis

  6 months

• Specificity of the score obtained

  Specificity of the score obtained using predicted probability cut-off with the prediction model for the diagnosis of TB

  6 months

Secondary Outcomes (22)

• Prevalence of TB among hospitalized children with SAM

  6 months

• Clinical characteristics of TB disease in hospitalized children with SAM

  6 months

• Bacteriological characteristics of TB disease in hospitalized children with SAM

  6 months

• Biological characteristics of TB disease in hospitalized children with SAM

  6 months

• Radiological characteristics of TB disease in hospitalized children with SAM

  6 months

Other Outcomes (1)

• Incremental cost-effectiveness ratio (ICER)

  32 months

Study Arms (1)

Prospective cohort

EXPERIMENTAL

Children included in the cohort will all be in the same arm. The patients will benefit from standard-of-care TB diagnosis with additional diagnostic methods.

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

Interventions

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

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.

Prospective cohort

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- Ongoing TB treatment or history of intake of anti-TB drugs in the last 3 months

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• UNITAID: collaborator

Study Sites (3)

Mulago National Referral Hospital

Kampala, Uganda

Location

Lusaka University Teaching Hospital

Lusaka, Zambia

Location

Arthur Davidson Children Hospital

Ndola, Zambia

Location

Related Publications (2)

• Chabala C, Roucher C, Ton Nu Nguyet MH, Babirekere E, Inambao M, Businge G, Kapula C, Shankalala P, Nduna B, Mulenga V, Graham S, Wobudeya E, Bonnet M, Marcy O; TB-Speed SAM study group. Development of tuberculosis treatment decision algorithms in children below 5 years hospitalised with severe acute malnutrition in Zambia and Uganda: a prospective diagnostic cohort study. EClinicalMedicine. 2024 Jun 20;73:102688. doi: 10.1016/j.eclinm.2024.102688. eCollection 2024 Jul.

  PMID: 39007063 RESULT

• d'Elbee M, Mafirakureva N, Chabala C, Huyen Ton Nu Nguyet M, Harker M, Roucher C, Businge G, Shankalala P, Nduna B, Mulenga V, Bonnet M, Wobudeya E, Marcy O, Dodd PJ. Treatment decision algorithms for tuberculosis screening and diagnosis in children below 5 years hospitalised with severe acute malnutrition: a cost-effectiveness analysis. EClinicalMedicine. 2025 Apr 19;83:103206. doi: 10.1016/j.eclinm.2025.103206. eCollection 2025 May.

  PMID: 40291345 RESULT

Related Links

• TB-Speed project official website

MeSH Terms

Conditions

Tuberculosis; Severe Acute Malnutrition; Malnutrition; Disease

Interventions

Algorithms; S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mathematical Concepts; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Olivier Marcy, MD, PhD

  University of Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Maryline Bonnet, MD, PhD

  Institut de Recherche pour le Développemnt (IRD) Montpellier, France

  PRINCIPAL INVESTIGATOR

• Eric Wobudeya, MD, PhD

  MU-JHU Care Ltd, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: TB-Speed SAM is a multicentric, prospective diagnostic cohort study assessing several diagnostic tests that could result in the development of a score and algorithm for TB treatment decision in hospitalised children with SAM.

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: January 27, 2020
• Study Start: November 4, 2019
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: December 10, 2025

Record last verified: 2025-02

Locations

ZA (2); UG (1)