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Simple urine test could spot pneumonia in kids without needles

NCT ID NCT07181200

Diagnosis Sponsor: Liverpool School of Tropical Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study will test whether a new urine-based test can accurately diagnose pneumococcal pneumonia in children under 5 in Malawi. Researchers will use 350 stored urine samples from healthy kids and those with pneumonia, comparing results to standard lab methods. If it works, this non-invasive test could replace painful procedures and help track vaccine effectiveness.

What this could mean

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

Active substance
serotype-specific urinary antigen detection (ssUAD) assay
What this could lead to
If successful, this could provide a simple, non-invasive urine test to diagnose pneumococcal pneumonia in children, improving care in high-burden areas.
What could go wrong
This is an early-stage diagnostic study using stored samples, not a treatment trial. The test may not reliably distinguish infection from harmless carriage in this setting.

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.

Participants

About 350 people

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

Started

Sep 2026

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.

Who is studied

Participants will be children aged 12-24 months enrolled in the NP Resistome study (COMREC reference P.10/24-1200) in the following groups; * Children hospitalised with pneumonia at Queen Elizabeth Central Hospital. * Children with pneumonia treated at Ndirande Health Centre. * Healthy children living in Ndirande community.

Ages

12 to 24 months

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 for healthy children in the community • Child aged between12-24 months. Exclusion criteria for healthy children in the community * Presence of any of the following symptoms: fever, cough, difficulty in breathing or fast breathing. * Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications. * Diagnosis of an immunosuppressive illness, including HIV infection. * Hospital admission within the past six months. Inclusion criteria for children with pneumonia in the community * Child aged between12-24 months. * Presence of all of the following symptoms: fever, cough, difficulty in breathing and fast breathing. * Participant has been prescribed antibiotics for treatment of a lower respiratory tract infection on this presentation. Exclusion criteria for children with pneumonia in the community * Severe anaemia, with a recorded haemoglobin level \< 70 grams per Litre. * Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications. * Diagnosis of an immunosuppressive illness, including HIV infection. * Hospital admission within the past six months. Inclusion criteria for children hospitalised with pneumonia * Child aged between 12-24 months. * Presence of all of the following symptoms: fever, cough, difficulty in breathing and fast breathing. * Participant has been prescribed antibiotics for treatment of a lower respiratory tract infection on this presentation. Exclusion criteria for children hospitalised with pneumonia * Severe anaemia, with a recorded haemoglobin level \< 70 grams per Litre. * Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications. * Diagnosis of an immunosuppressive illness, including HIV infection. * Hospital admission within the past six months. Inclusion criteria for children re-hospitalised with pneumonia * Child aged between12-24 months. * Presence of all of the following symptoms: fever, cough, difficulty in breathing and fast breathing. * Participant has been prescribed antibiotics for treatment of a lower respiratory tract infection on this presentation. * Hospital admission to ANY hospital with a lower respiratory tract infection within the past 3 months. Exclusion criteria for children re-hospitalised with pneumonia * Severe anaemia, with a recorded haemoglobin level \< 70 grams per Litre. * Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications. * Diagnosis of an immunosuppressive illness, including HIV infection.

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Conditions

The condition(s) this trial relates to.

bacterial pneumonia pneumonia streptococcal pneumonia

As listed by the trial registrant

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

Pneumonia Pneumonia - bacterial

How to take part

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

  1. The places running it

    1 site. 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

  • Malawi Liverpool Wellcome Research Programme

    RECRUITING

    Blantyre, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.