TuberculosisNCT04240990
Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition (TB-Speed SAM)
A study testing Development of a score and algorithm for TB treatment decision in hospitalised children with SAM. in people with Tuberculosis and Severe Acute Malnutrition, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Tuberculosis, Severe Acute Malnutrition
- What is being tested?
- Development of a score and algorithm for TB treatment decision in hospitalised children with SAM.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Nov 2019to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Ongoing TB treatment or history of intake of anti-TB drugs in the last 3 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Zambia2 sites
Lusaka University Teaching Hospital
Lusaka
Arthur Davidson Children Hospital
Ndola
About this study
Official title: Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition
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).
Read the detailed description
There is now strong evidence that undiagnosed and untreated TB increases the risk of death in children, especially those severely malnourished who are highly vulnerable. Specific decision-making tools are therefore urgently needed to guide clinicians from high TB burden and low-income countries to initiate treatment quickly in children with SAM with suspected TB.
A diagnostic prediction score and algorithm was recently proposed by the investigators for TB treatment decision in HIV-infected children with presumptive TB (developed in the ANRS 12229 PAANTHER 01 study). Based on easily collected clinical features, chest X-Ray (CXR), Xpert MTB/RIF, and abdominal ultrasonography, the score aims to help clinicians make a same-day treatment decision. Such a prediction score improving TB diagnosis and shortening time to treatment initiation would be a key benefit in children with SAM.
Based on this experience, the investigators are proposing a diagnostic cohort study enrolling hospitalized severely malnourished children. The study will include the evaluation of several diagnostic tests that could be integrated in the development of a prediction model and subsequent score for the diagnosis of TB in hospitalized children with SAM. This will include Xpert MTB/RIF Ultra performed on one nasopharyngeal aspirate (NPA) and one stool sample, CXR, Quantiferon (QFT) Interferon-Gamma Release Assay (IGRA), Monocyte-to-lymphocyte ratio (MLR), and ultrasonography, which has shown its interest for the diagnosis of TB in both HIV-infected adults and children. In the PAANTHER study, it detected abdominal lymphadenopathy in 50% of culture confirmed TB cases and 35% of all confirmed and unconfirmed cases, with a specificity of 85%.
Using logistic regression, a score will be developed for TB diagnosis, considering confirmed and unconfirmed TB as reference diagnosis, in hospitalized children with SAM. As a secondary objective, and in order to reduce costs, sample collection, and complexity of the diagnostic process, a first-step screening score (excluding Ultra, abdominal ultrasound, and CXR if possible) will be developed to identify children with presumptive TB who would benefit from further diagnostic testing.
Both scores will be internally validated using resampling and will be incorporated in a stepwise algorithm to guide practical implementation of the screening and diagnosis process. The stepwise algorithm will be discussed with local clinicians involved in the study to better adapt it for future use in their routine practice.
The study will be implemented at inpatient nutrition centres from three selected tertiary hospitals in Uganda, and Zambia. A total of 720 children <5 years old with WHO-defined severe acute malnutrition will be enrolled, that is approximately 240 participants per hospital.
- Conditions
- Tuberculosis, Severe Acute Malnutrition
- Being tested
- Development of a score and algorithm for TB treatment decision in hospitalised children with SAM.
- Keywords
- Tuberculosis, Child, Malnutrition, Diagnosis, Screening
- Medical subject headings
- Tuberculosis, Severe Acute Malnutrition, Malnutrition, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Development of a score and algorithm for TB treatment decision in hospitalised children with SAM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (22)
Prevalence of TB among hospitalized children with SAM
Proportion of confirmed and unconfirmed TB in the study population
Measured: 6 months
Clinical characteristics of TB disease in hospitalized children with SAM
Signs and symptoms of children with tuberculosis (confirmed and unconfirmed)
Measured: 6 months
Bacteriological characteristics of TB disease in hospitalized children with SAM
Bacteriological characteristics (mycobacterial culture and drug susceptibility testing) of children with tuberculosis (confirmed and unconfirmed)
Measured: 6 months
Biological characteristics of TB disease in hospitalized children with SAM
Haematological and immunological characteristics (full blood count, transaminases, CRP, IFN gamma) of children with tuberculosis (confirmed and unconfirmed)
Measured: 6 months
Radiological characteristics of TB disease in hospitalized children with SAM
Radiological features (chest X-ray and abdominal US) of children with tuberculosis (confirmed and unconfirmed)
Measured: 6 months
Sensitivity of the score obtained
Sensitivity of the score obtained using predicted probability cut-off with the screening prediction model for the identification of children with presumptive TB requiring further diagnostic evaluation
Measured: 6 months
Specificity of the score obtained
Specificity of the score obtained using predicted probability cut-off with the screening prediction model for the identification of children with presumptive TB requiring further diagnostic evaluation
Measured: 6 months
Estimated time to TB treatment decision in hospitalized children with SAM
Estimated time to TB treatment decision in hospitalized children with SAM, with and without presumptive TB based on the first-step screening prediction score
Measured: 6 months
Diagnostic accuracy measures: 1/ Sensitivity of the different tests evaluated for the diagnosis of TB
Sensitivity of the different tests evaluated for the diagnosis of TB (Ultra performed on NPA and stools, CXR, abdominal ultrasound, QFT, MLR, CRP)
Measured: 6 months
Diagnostic accuracy measures: 2/ Specificity of the different tests evaluated for the diagnosis of TB
Specificity of the different tests evaluated for the diagnosis of TB (Ultra performed on NPA and stools, CXR, abdominal ultrasound, QFT, MLR, CRP)
Measured: 6 months
Diagnostic accuracy measures: 3/ Negative predictive value of the different tests evaluated for the diagnosis of TB
Negative predictive value of the different tests evaluated for the diagnosis of TB (Ultra performed on NPA and stools, CXR, abdominal ultrasound, QFT, MLR, CRP)
Measured: 6 months
Diagnostic accuracy measures: 4/ Positive predictive value of the different tests evaluated for the diagnosis of TB
Positive predictive value of the different tests evaluated for the diagnosis of TB (Ultra performed on NPA and stools, CXR, abdominal ultrasound, QFT, MLR, CRP)
Measured: 6 months
Diagnostic accuracy measures: 5/ AUROC of diagnostic prediction models with and without the different tests results
Area Under the Receiver Operating Characteristics curve
Measured: 6 months
Diagnostic accuracy of Ultra performed on one NPA and one stool sample against a specific microbiological reference standard including Ultra and mycobacterial culture from gastric aspirates
Proportion of NPAs and stool samples with mycobacterium tuberculosis detected using Ultra
Measured: 6 months
Proportion of children with NPA and stool samples collected as per study protocol
Feasibility of NPA and stool samples collection defined as the proportion of children with NPA and stool samples collected as per study protocol
Measured: 6 months
Proportion of NPA-related adverse events (AEs)
Safety of NPA collection defined as proportion of AEs (vomiting, nose bleeding, low oxygen saturation, respiratory distress) occurring during NPA
Measured: 6 months
Tolerability of NPA collection: 1/ Discomfort/pain/distress experienced by the child as assessed by the child
Discomfort/pain/distress experienced by the child during NPA collection, as assessed by the child using the Wong-Baker face scale (in a subset of children).
Scale range: 0 (no hurt) - 5 (hurts worst)
Measured: Within 3 days of inclusion
Tolerability of NPA collection: 2/ Discomfort/pain/distress experienced by the child as assessed by the parents
Discomfort/pain/distress experienced by the child during NPA collection, as assessed by the parents using the visual analog scale (in a subset of children).
Scale range: 0 (no pain) - 10 (pain as bad as it could possibly be)
Measured: Within 3 days of inclusion
Tolerability of NPA collection: 3/ Discomfort/pain/distress experienced by the child as assessed by the nurse
Discomfort/pain/distress experienced by the child during NPA collection, as assessed by the nurses using the "Face Legs Activity Cry Consolability" behavioral pain scale (in a subset of children).
Total score range: 0 (relaxed and comfortable) - 10 (severe discomfort/pain). Each item of the FLACC scale - Face, Legs, Activity, Cry, Consolability - has 3 possible quotes: 0 or 1 or 2, with a precise description provided to help with the rating. The total score is obtained by adding individual item scores.
Measured: Within 3 days of inclusion
Mortality at 6 months
Mortality at 6 months in children with SAM, with or without TB treatment
Measured: 6 months
Percentage weight gain 6 months
Weight gain and WHZ at 6 months in children with SAM, with or without anti-TB treatment
Measured: 6 months
TB treatment outcomes
TB treatment outcomes as defined per WHO guidelines (Cured, Treatment completed, Treatment failed, Died, Lost to follow-up, Not evaluated, Treatment success)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start4 Nov 2019
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- UNITAID
- Responsible party
- Sponsor
- Investigators
- Olivier Marcy, MD, PhD, Principal investigator, University of Bordeaux, FranceMaryline Bonnet, MD, PhD, Principal investigator, Institut de Recherche pour le Développemnt (IRD) Montpellier, FranceEric Wobudeya, MD, PhD, Principal investigator, MU-JHU Care Ltd, Kampala, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240990
- Sponsor's protocol ID
- C18-28
- Status last verified
- Feb 2025
- First submitted
- 24 Oct 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39007063d'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.
PubMed 40291345
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT04240990
- Acronym / sponsor ID
- C18-28
- Conditions
- Tuberculosis, Severe Acute Malnutrition
- Keywords
- Tuberculosis, Child, Malnutrition, Diagnosis, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- UNITAID
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
There is now strong evidence that undiagnosed and untreated TB increases the risk of death in children, especially those severely malnourished who are highly vulnerable. Specific decision-making tools are therefore urgently needed to guide clinicians from high TB burden and low-income countries to initiate treatment quickly in children with SAM with suspected TB.
A diagnostic prediction score and algorithm was recently proposed by the investigators for TB treatment decision in HIV-infected children with presumptive TB (developed in the ANRS 12229 PAANTHER 01 study). Based on easily collected clinical features, chest X-Ray (CXR), Xpert MTB/RIF, and abdominal ultrasonography, the score aims to help clinicians make a same-day treatment decision. Such a prediction score improving TB diagnosis and shortening time to treatment initiation would be a key benefit in children with SAM.
Based on this experience, the investigators are proposing a diagnostic cohort study enrolling hospitalized severely malnourished children. The study will include the evaluation of several diagnostic tests that could be integrated in the development of a prediction model and subsequent score for the diagnosis of TB in hospitalized children with SAM. This will include Xpert MTB/RIF Ultra performed on one nasopharyngeal aspirate (NPA) and one stool sample, CXR, Quantiferon (QFT) Interferon-Gamma Release Assay (IGRA), Monocyte-to-lymphocyte ratio (MLR), and ultrasonography, which has shown its interest for the diagnosis of TB in both HIV-infected adults and children. In the PAANTHER study, it detected abdominal lymphadenopathy in 50% of culture confirmed TB cases and 35% of all confirmed and unconfirmed cases, with a specificity of 85%.
Using logistic regression, a score will be developed for TB diagnosis, considering confirmed and unconfirmed TB as reference diagnosis, in hospitalized children with SAM. As a secondary objective, and in order to reduce costs, sample collection, and complexity of the diagnostic process, a first-step screening score (excluding Ultra, abdominal ultrasound, and CXR if possible) will be developed to identify children with presumptive TB who would benefit from further diagnostic testing.
Both scores will be internally validated using resampling and will be incorporated in a stepwise algorithm to guide practical implementation of the screening and diagnosis process. The stepwise algorithm will be discussed with local clinicians involved in the study to better adapt it for future use in their routine practice.
The study will be implemented at inpatient nutrition centres from three selected tertiary hospitals in Uganda, and Zambia. A total of 720 children <5 years old with WHO-defined severe acute malnutrition will be enrolled, that is approximately 240 participants per hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | Experimental | Other: Development of a score and algorithm for TB treatment decision in hospitalised children with SAM.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. |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Ongoing TB treatment or history of intake of anti-TB drugs in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Prospective cohort |
Primary outcome
Sensitivity of the score obtained
Time frame: 6 months
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
Specificity of the score obtained
Time frame: 6 months
Specificity of the score obtained using predicted probability cut-off with the prediction model for the diagnosis of TB
22 secondary outcomes
Prevalence of TB among hospitalized children with SAM
Time frame: 6 months
Clinical characteristics of TB disease in hospitalized children with SAM
Time frame: 6 months
Bacteriological characteristics of TB disease in hospitalized children with SAM
Time frame: 6 months
Biological characteristics of TB disease in hospitalized children with SAM
Time frame: 6 months
Radiological characteristics of TB disease in hospitalized children with SAM
Time frame: 6 months
Sensitivity of the score obtained
Time frame: 6 months
Specificity of the score obtained
Time frame: 6 months
Estimated time to TB treatment decision in hospitalized children with SAM
Time frame: 6 months
Diagnostic accuracy measures: 1/ Sensitivity of the different tests evaluated for the diagnosis of TB
Time frame: 6 months
Diagnostic accuracy measures: 2/ Specificity of the different tests evaluated for the diagnosis of TB
Time frame: 6 months
Diagnostic accuracy measures: 3/ Negative predictive value of the different tests evaluated for the diagnosis of TB
Time frame: 6 months
Diagnostic accuracy measures: 4/ Positive predictive value of the different tests evaluated for the diagnosis of TB
Time frame: 6 months
Diagnostic accuracy measures: 5/ AUROC of diagnostic prediction models with and without the different tests results
Time frame: 6 months
Diagnostic accuracy of Ultra performed on one NPA and one stool sample against a specific microbiological reference standard including Ultra and mycobacterial culture from gastric aspirates
Time frame: 6 months
Proportion of children with NPA and stool samples collected as per study protocol
Time frame: 6 months
Proportion of NPA-related adverse events (AEs)
Time frame: 6 months
Tolerability of NPA collection: 1/ Discomfort/pain/distress experienced by the child as assessed by the child
Time frame: Within 3 days of inclusion
Tolerability of NPA collection: 2/ Discomfort/pain/distress experienced by the child as assessed by the parents
Time frame: Within 3 days of inclusion
Tolerability of NPA collection: 3/ Discomfort/pain/distress experienced by the child as assessed by the nurse
Time frame: Within 3 days of inclusion
Mortality at 6 months
Time frame: 6 months
Percentage weight gain 6 months
Time frame: 6 months
TB treatment outcomes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 39007063Chabala 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.
- Results publication: PubMed 40291345d'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.
- TB-Speed project official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Marcy, MD, PhD principal investigator
University of Bordeaux, France
Maryline Bonnet, MD, PhD principal investigator
Institut de Recherche pour le Développemnt (IRD) Montpellier, France
Eric Wobudeya, MD, PhD principal investigator
MU-JHU Care Ltd, Kampala, Uganda
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Development of a score and algorithm for TB treatment decision in hospitalised children with SAM. in people with Tuberculosis and Severe Acute Malnutrition, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Zambia, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the score obtained (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240990, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.