An observational study in Pneumonia and Pneumonia - Bacterial, sponsored by Liverpool School of Tropical Medicine. Recruiting at 1 site in Malawi. Open to participants aged 12 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Liverpool School of Tropical Medicine · Observational
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 (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.
Study type:
This is a nested case-control sub-study within the multi-site, observational NP Resistome study (COMREC reference P.10/24-1200).
Background:
Pneumococcal pneumonia is a leading cause of morbidity and mortality among children under five, especially in sub-Saharan Africa. Accurate diagnosis remains a challenge due to the need for invasive specimen collection and poor sensitivity of standard culture-based diagnostic tests, particularly after antibiotic use. Serotype-specific urinary antigen detection (ssUAD) offers a promising, non-invasive alternative for serotype surveillance and diagnosis of pneumococcal disease. Serotype-specific identification provided by ssUAD is crucial for monitoring the impact of vaccines and informing public health interventions. The ssUAD test is a Luminex-based urine antigen capture assay developed by the UK Health Security Agency (UKHSA) that targets 24 pneumococcal serotypes, with good sensitivity and specificity among adults with community-acquired pneumonia in the UK. Further investigation is required to determine its ability/utility to identify invasive disease among children, particularly in settings like sub-Saharan Africa, where high rates of asymptomatic carriage may affect diagnostic accuracy.
Broad Objective: To evaluate the performance of the ssUAD test in detecting pneumococcal carriage and distinguishing it from invasive disease among children under five years old in Blantyre, Malawi.
Specific Objectives:
Methodology:
The investigators will test 350 existing urine samples that have already been collected from children as part of the NP Resistome study (COMREC reference P.10/24-1200), including healthy children in the community, children with pneumonia in the community, and children hospitalised with pneumonia at the time of recruitment. 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. Urine samples will be aliquoted into 1.8 mL cryotubes and stored at -80°C at Malawi Liverpool Wellcome Research Programme (MLW) laboratory in Malawi. Aliquots from each urine sample will be tested using the ssUAD in the UK, as the assay is not currently available in Malawi. However, the investigators are working towards developing and evaluating the assay locally as part of future implementation efforts. Urinary detection of pneumococcal serotypes will be compared with both culture-based and metagenomic sequencing results from nasopharyngeal swab (NPS) samples taken as part of the main study.
Expected results and dissemination: This sub-study will generate key data on the prevalence of pneumococcal serotype-specific urinary antigens in children with pneumonia and healthy controls. It will improve understanding of ssUAD performance as a surveillance tool in this setting, help distinguish antigenuria due to carriage from disease, and refine diagnostic thresholds for use in high-carriage and disease-burden settings. Study findings will inform surveillance, pneumonia diagnostics, and vaccine impact assessments in LMICs. Results will be shared with COMREC, the Blantyre District Health Office, at scientific conferences, both local and international, and in peer-reviewed publications.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 350 is above the median of 252 across 535 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Liverpool School of Tropical Medicine is the lead sponsor of 57 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be children aged 12-24 months enrolled in the NP Resistome study (COMREC reference P.10/24-1200) in the following groups;
Inclusion criteria for healthy children in the community
Exclusion criteria for healthy children in the community
Inclusion criteria for children with pneumonia in the community
Exclusion criteria for children with pneumonia in the community
Inclusion criteria for children hospitalised with pneumonia
Exclusion criteria for children hospitalised with pneumonia
Inclusion criteria for children re-hospitalised with pneumonia
Exclusion criteria for children re-hospitalised with pneumonia
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy children living in Ndirande community, aged between 12 and 24 months at recruitment.
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.
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.
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.
Number of participants with serotype-specific urinary pneumococcal antigen detected
Number of participants with serotype-specific pneumococcal antigen detected in urine samples taken at recruitment, using an extended-specificity multiplex urine immunoassay.
Time frame: At the time of recruitment/participant enrolment.
Number of participants with nasopharyngeal carriage of Streptococcus pneumoniae (detected based on culture)
Detection of Streptococcus pneumoniae following culture of nasopharyngeal swab samples from participants on Sheep Blood Agar with 5 µg/mL of Gentamicin (GBA).
Time frame: At time of recruitment/enrolment.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data generated from this sub-study will be shared with collaborators under restricted-access data sharing agreements. All shared datasets will be anonymised and used solely for the purposes outlined in this protocol, in accordance with institutional and ethical guidelines.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Urinary pneumococcal data will be available within 12 months of completion of data collection; approximately October 2027. Clinical metadata from the parent study (ISRCTN64027792) will only be available to scientific collaborators, or by application from non-collaborating scientific researchers.
Access criteria: Anonymised, curated urinary pneumococcal data and clinical metadata will be shared with scientific collaborators. Non-collaborating scientific researchers must submit a formal project proposal for review by investigators to access the data, which if approved, will be released following receipt of a signed data user's agreement setting out roles and responsibilities of data originators and recipients.
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