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NCT07181200

Urine Pneumococcal Antigen Project

Sponsor: Liverpool School of Tropical Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: Accelerating the Development of an Extended-specificity Multiplex Urine Immunoassay for the Diagnosis and Serotyping of Pneumococcal Pneumonia in High Carriage and Disease Burden Settings Like Malawi

Key Details

Gender

All

Age Range

12 Months - 24 Months

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2025-10

Completion Date

2027-08

Last Updated

2025-09-18

Healthy Volunteers

Yes

Conditions

Pneumonia Pneumonia - Bacterial

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.

Clinical Research Directory

Urine Pneumococcal Antigen Project

Summary

Key Details

Conditions

Eligibility Criteria