Urine Pneumococcal Antigen Project

NCT07181200 | Not Yet Recruiting

• 1 other identifier: P.0725-1685
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pneumonia; Pneumonia - Bacterial

Keywords

Urinary pneumococcal antigen; Serotype-specific urinary antigen detection

Outcome Measures

Primary Outcomes (1)

• Serotype specific urinary pneumococcal antigen detection

  Serotype-specific urinary pneumococcal antigen detection in urine samples taken at recruitment, using an extended-specificity multiplex urine immunoassay.

  At the time of recruitment/participant enrolment.

Secondary Outcomes (1)

• Nasopharyngeal pneumococcal carriage

  At time of recruitment/enrolment.

Study Arms (4)

Healthy community

Healthy children living in Ndirande community, aged between 12 and 24 months at recruitment.

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.

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.

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.

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Child aged between12-24 months.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Severe anaemia, with a recorded haemoglobin level \< 70 grams per Litre.

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Malawi Liverpool Wellcome Programme: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples.

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Brenda Kwambana-Adams, PhD

  LSTM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles B Nkhata, Pre-MSc

CONTACT

+265990557781; cbnkhata@mlw.mw

Brenda Kwambana-Adams, PhD

CONTACT

bkwambana@mlw.mw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.