Urine Pneumococcal Antigen Test in Children with Pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This nested case-control analysis sits within a multi-site observational study and uses a urine-based, serotype-specific pneumococcal antigen assay to differentiate carriage from invasive disease in young children. The assay is designed to provide serotype information to help monitor vaccine impact. The study is conducted in Blantyre, Malawi, and compares healthy children with those presenting pneumonia to evaluate test performance. It builds on existing surveillance infrastructure and aims to improve non-invasive diagnosis of pneumococcal disease in a high-burden setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Malawi Liverpool Wellcome Research Programme
  Blantyre, Malawi Recruiting

Study contacts

• Principal investigator: Brenda Kwambana-Adams, PhD — Lstm
• Study coordinator: Charles B Nkhata, Pre-MSc
• Email: cbnkhata@mlw.mw
• Phone: +265990557781

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.