Urine Pneumococcal Antigen Project

Sponsor
Liverpool School of Tropical Medicine
Study ID
NCT07181200
Status
Not Yet Recruiting

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Conditions

  • Pneumonia
  • Pneumonia - Bacterial

Eligibility Criteria

Sex
ALL
Age
12 Months - 24 Months
Healthy Volunteers
Accepted

Study Details

Background:Pneumonia caused by the bacteria Streptococcus pneumoniae is a leading cause of death among children under five years of age, especially in sub-Saharan Africa. Accurate diagnosis remains challenging due to the need for invasive procedures to obtain samples for culture-based diagnostic tests, which are not very sensitive for detecting S.pneumoniae, particularly after antibiotic use. Serotype-specific urinary antigen detection (ssUAD) assays are a promising, non-invasive alternative for the surveillance and diagnosis of pneumococcal disease. Importantly, they can identify different serotypes of S.pneumoniae, which is crucial for monitoring vaccine impact. However, the ability of the ssUAD to identify invasive disease due to S.pneumoniae has not been studied in children in sub-Saharan Africa, where high rates of asymptomatic carriage may affect diagnostic accuracy. Aim: The overall aim of this study is to evaluate the performance of the ssUAD test to detect pneumococcal carriage, and distinguish it from invasive disease, among children under five years old in Blantyre, Malawi. Methods:This study will test 350 existing urine samples that have already been collected from children as part of the NP Resistome study (Protocol V 5.0, LSTM reference 24-076), including healthy children in the community, children with pneumonia in the community, and children hospitalised with pneumonia. Participants of the NP Resistome study will be recruited from Ndirande Health Centre (NHC), Gateway Primary Care Centre (GPCC) and Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi. Aliquots from each urine sample will be tested using the ssUAD in the UK, as the assay is not currently available in Malawi. Urinary detection of pneumococcal serotypes will be compared with both culture-based and metagenomic sequencing results from nasopharyngeal swab samples taken as part of the main study.

Key Dates

First listed
Sep 18, 2025
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Healthy community
    Healthy children living in Ndirande community, aged between 12 and 24 months at recruitment.
  • Arm: Community pneumonia
    Children aged between 12 and 24 months who have presented to Ndirande Health Centre with a pneumonia clinical syndrome (based on the WHO definition of fever, cough, tachypnoea and dyspnoea) for which they are prescribed antibiotic therapy.
  • Arm: Hospital pneumonia - first admission
    Children aged between 12 and 24 months who have been admitted to Queen Elizabeth Central Hospital for the first time with a pneumonia clinical syndrome (based on the WHO definition of fever, cough, tachypnoea and dyspnoea) for which they are prescribed antibiotic therapy.
  • Arm: Hospital pneumonia - re-admission
    Children aged between 12 and 24 months who have been re-admitted to Queen Elizabeth Central Hospital with a pneumonia clinical syndrome (based on the WHO definition of fever, cough, tachypnoea and dyspnoea) for which they are prescribed antibiotic therapy, within 3 months of a previous hospitalisation with pneumonia.

Primary Outcome Measure

Serotype specific urinary pneumococcal antigen detection [ Time Frame: At the time of recruitment/participant enrolment. ]

Central Contacts

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