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New decision tool aims to catch childhood TB earlier in africa

NCT ID NCT06593080

Disease control Sponsor: Chishala Chabala Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new way to help doctors in Mozambique and Zambia decide if a sick child has tuberculosis (TB). The approach uses simple checklists and decision guides, supported by a computer system, to improve diagnosis and treatment, especially for children with HIV or severe malnutrition. Over 30,000 children will take part, and the goal is to see if this tool helps more kids get the right TB treatment faster.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Treatment Decision Algorithms (TDA) and Clinical Decision Support System (CDSS)
What this could lead to
If successful, this could provide a practical, evidence-based way to diagnose and treat childhood TB more effectively in resource-limited settings, reducing deaths and severe illness.
What could go wrong
This is a large implementation study, not a drug trial, so it tests a process rather than a new treatment. Results may vary by location and depend on how well health workers adopt the new system.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30,240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 14 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention: * All sick children aged below 15 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases through community- or facility-based household contact tracing. * Children with presumptive TB. The WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) . The definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses. High-risk group will be defined using the definition in WHO-suggested TDAs A\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being \<5 years with a weight-for-height Z score (WHZ) \< -3 SDs or mid-upper arm circumference (MUAC) \< 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score \< -3SD. Exclusion Criteria: There will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease nutritional deficiency disease protein-energy malnutrition Severe Acute Malnutrition tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child health HIV Severe acute malnutrition Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allessandras Urban Health Centre

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Chaisa Urban Health Centre

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Chawama Urban Health Centre

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Chipepo Rural Health Centre

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Chiwempala Urban Health Centre

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Fisenge Urban Health Centre

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Habulile Rural Health Centre

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Hachipilika Rural Health Centre

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Jamba Rural Health Centre

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Kabundi East Urban Health Clinic

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Kalomo District Hospital

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Kalomo Urban Health Centre

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Kapululira Rural Health Centre

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Kasompe Urban Health Centre

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Kawama Urban Health Centre

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Lusitu Rural Health Centre

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Malaika Urban Health Centre

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Mawaya Urban Health Centre

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Mikomfwa Urban Health Centre

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Mtendere Mission Referal hospital

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Muchinshi Rural Health Centre

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Namwianga Urban Health Centre

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Nchanga 1 Urban Health Centre

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Nchanga North Referal Hospital

    RECRUITING

    Chingola, Copperbelt, Zambia

  • Nkandanzovu Rural Health Centre

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Roan Antelope General Hospital

    RECRUITING

    Luanshya, Copperbelt, Zambia

  • Siachitema Rural Health Centre

    RECRUITING

    Kalomo, Southern Province, Zambia

  • Sikoongo Rural Health Centre

    RECRUITING

    Chirundu, Southern Province, Zambia

  • Thomson District Hospital

    RECRUITING

    Luanshya, Copperbelt, Zambia

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