PneumoniaUPAPNCT07181200
Urine Pneumococcal Antigen Project
An observational study of Pneumonia and Pneumonia - Bacterial, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumonia - Bacterial
- How many people
- 350 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Sep 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Child aged between12-24 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brenda Kwambana-Adams, PhD contact
Malawi1 site, 1 recruiting
- Recruiting
Malawi Liverpool Wellcome Research Programme
Blantyre
Charles B Nkhata, BSc, +265 990 55 77 81, cbnkhata@mlw.mw
Brenda Kwambana-Adams, PhD, +447903209866, Brenda.Kwambana@lstmed.ac.uk
About this 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
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.
Read more
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.
Read the detailed description
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:
- To determine the prevalence of serotype-specific pneumococcal antigens in urine among children under five years of age with pneumonia compared to their healthy counterparts.
- To characterise the association between the detection of serotype-specific antigens in urine and nasopharyngeal pneumococcal carriage among children.
- To define revised ssUAD thresholds that may distinguish pneumococcal carriage from disease, to support field evaluations and inform diagnostic and surveillance strategies in Malawi and similar settings.
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.
- Conditions
- Pneumonia, Pneumonia - Bacterial
- Keywords
- Urinary pneumococcal antigen, Serotype-specific urinary antigen detection
- Medical subject headings
- Pneumonia, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of recruitment/participant enrolment.
Secondary outcomes (1)
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).
Measured: At time of recruitment/enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Sep 2026
- Primary completionJan 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Malawi Liverpool Wellcome Programme
- Responsible party
- Sponsor
- Investigators
- Brenda Kwambana-Adams, PhD, Principal investigator, LSTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181200
- Sponsor's protocol ID
- P.0725-1685
- Acronym
- UPAP
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07181200
- Acronym / sponsor ID
- UPAP / P.0725-1685
- Conditions
- Pneumonia, Pneumonia - Bacterial
- Keywords
- Urinary pneumococcal antigen, Serotype-specific urinary antigen detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Malawi Liverpool Wellcome Programme
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To determine the prevalence of serotype-specific pneumococcal antigens in urine among children under five years of age with pneumonia compared to their healthy counterparts.
- To characterise the association between the detection of serotype-specific antigens in urine and nasopharyngeal pneumococcal carriage among children.
- To define revised ssUAD thresholds that may distinguish pneumococcal carriage from disease, to support field evaluations and inform diagnostic and surveillance strategies in Malawi and similar settings.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Child aged between12-24 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with serotype-specific urinary pneumococcal antigen detected
Time frame: At the time of recruitment/participant enrolment.
Number of participants with serotype-specific pneumococcal antigen detected in urine samples taken at recruitment, using an extended-specificity multiplex urine immunoassay.
1 secondary outcome
Number of participants with nasopharyngeal carriage of Streptococcus pneumoniae (detected based on culture)
Time frame: At time of recruitment/enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brenda Kwambana-Adams, PhD contact
Brenda Kwambana-Adams, PhD principal investigator
LSTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pneumonia - Bacterial, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles B Nkhata, Pre-MSc (+265990557781, cbnkhata@mlw.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with serotype-specific urinary pneumococcal antigen detected (time frame: At the time of recruitment/participant enrolment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.