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Could a simple TB test save kids with pneumonia?

NCT ID NCT03831906

Diagnosis Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding a rapid tuberculosis (TB) test to standard care for children hospitalized with severe pneumonia could reduce deaths. Over 2,500 children aged 2 to 59 months in six high-TB countries were enrolled. The test, called Xpert MTB/RIF Ultra, was done on nose and stool samples at admission to find TB early and start treatment right away.

What this could mean

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

Active substance
Xpert MTB/RIF Ultra diagnostic test
What this could lead to
If successful, this approach could help identify tuberculosis earlier in children with pneumonia, potentially reducing deaths by starting treatment sooner.
What could go wrong
This is a completed diagnostic trial, not a treatment study. The test may not significantly lower mortality, and results may vary across different settings.

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

2,570 people

The number who actually took part.

Started

Mar 2019

Finished

Jun 2021

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

2 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Children aged 2 to 59 months 2. Newly hospitalized for severe pneumonia defined using WHO criteria as cough or difficulty in breathing with: 1. Peripheral oxygen saturation \< 90% or central cyanosis, or 2. Severe respiratory distress (e.g. grunting, nasal flaring, very severe chest indrawing), or 3. Signs of pneumonia, defined as cough or difficulty in breathing with fast breathing (tachypnea) and/or chest indrawing, with any of the following danger signs: * Inability to breastfeed or drink, * Persistent vomiting * Lethargy or reduced level of consciousness * Convulsions, * Stridor in calm child * Severe malnutrition 3. Informed consent signed by parent/guardian Exclusion criteria: \- Ongoing TB treatment or history of intake of anti-TB drugs in the last 6 months

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Conditions

The condition(s) this trial relates to.

COVID-19 pneumonia tuberculosis

As listed by the trial registrant

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

COVID19 Severe pneumonia Tuberculosis

Contacts and locations

Locations

  • Angré University Teaching Hospital

    Abidjan, Côte d’Ivoire

  • Arthur Davidson Children Hospital

    Ndola, Zambia

  • Biyem Assi District Hospital

    Yaoundé, Cameroon

  • Chantal Biya Foundation

    Yaoundé, Cameroon

  • Cocody University Teaching Hospital

    Abidjan, Côte d’Ivoire

  • Holy Innocents Children's Hospital

    Mbarara, Uganda

  • Jinja Regional Reference Hospital

    Jinja, Uganda

  • José Macamo General Hospital

    Maputo, Mozambique

  • Kampong Cham Provincial Referral Hospital

    Kampong Cham, Cambodia

  • Lusaka University Teaching Hospital

    Lusaka, Zambia

  • Maputo Central Hospital

    Maputo, Mozambique

  • Mulago National Referral Hospital

    Kampala, Uganda

  • National Pediatric Hospital

    Phnom Penh, Cambodia

  • Takeo Provincial Referral Hospital

    Takeo, Cambodia

  • Treichville University Teaching Hospital

    Abidjan, Côte d’Ivoire

  • Yopougon University Teaching Hospital

    Abidjan, Côte d’Ivoire

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