[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606872":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":26,"locations":10,"responsibleParty":34,"collaborators":36,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":10},{"fullName":5,"class":6},"Liverpool School of Tropical Medicine","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Healthy community",null,"Healthy children living in Ndirande community, aged between 12 and 24 months at recruitment.",{"label":13,"type":10,"description":14,"interventionNames":10},"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.",{"label":16,"type":10,"description":17,"interventionNames":10},"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.",{"label":19,"type":10,"description":20,"interventionNames":10},"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.",[22],{"name":23,"affiliation":24,"role":25},"Brenda Kwambana-Adams, PhD","LSTM","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Charles B Nkhata, Pre-MSc","CONTACT","+265990557781","cbnkhata@mlw.mw",{"name":23,"role":29,"phone":10,"phoneExt":10,"email":33},"bkwambana@mlw.mw",{"type":35,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[37],{"name":38,"class":6},"Malawi Liverpool Wellcome Programme","100606872","urine-pneumococcal-antigen-project-100606872",false,"NCT07181200","Urine Pneumococcal Antigen Project","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","UPAP","Inclusion criteria for healthy children in the community\n\n• Child aged between12-24 months.\n\nExclusion criteria for healthy children in the community\n\n* Presence of any of the following symptoms: fever, cough, difficulty in breathing or fast breathing.\n* Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications.\n* Diagnosis of an immunosuppressive illness, including HIV infection.\n* Hospital admission within the past six months.\n\nInclusion criteria for children with pneumonia in the community\n\n* Child aged between12-24 months.\n* Presence of all of the following symptoms: fever, cough, difficulty in breathing and fast breathing.\n* Participant has been prescribed antibiotics for treatment of a lower respiratory tract infection on this presentation.\n\nExclusion criteria for children with pneumonia in the community\n\n* Severe anaemia, with a recorded haemoglobin level \\\u003C 70 grams per Litre.\n* Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications.\n* Diagnosis of an immunosuppressive illness, including HIV infection.\n* Hospital admission within the past six months.\n\nInclusion criteria for children hospitalised with pneumonia\n\n* Child aged between 12-24 months.\n* Presence of all of the following symptoms: fever, cough, difficulty in breathing and fast breathing.\n* Participant has been prescribed antibiotics for treatment of a lower respiratory tract infection on this presentation.\n\nExclusion criteria for children hospitalised with pneumonia\n\n* Severe anaemia, with a recorded haemoglobin level \\\u003C 70 grams per Litre.\n* Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications.\n* Diagnosis of an immunosuppressive illness, including HIV infection.\n* Hospital admission within the past six months.\n\nInclusion criteria for children re-hospitalised with pneumonia\n\n* Child aged between12-24 months.\n* Presence of all of the following symptoms: fever, cough, difficulty in breathing and fast breathing.\n* Participant has been prescribed antibiotics for treatment of a lower respiratory tract infection on this presentation.\n* Hospital admission to ANY hospital with a lower respiratory tract infection within the past 3 months.\n\nExclusion criteria for children re-hospitalised with pneumonia\n\n* Severe anaemia, with a recorded haemoglobin level \\\u003C 70 grams per Litre.\n* Currently taking long-term antibiotic prophylaxis, TB treatment or immunosuppressive medications.\n* Diagnosis of an immunosuppressive illness, including HIV infection.",true,"ALL","12 Months","24 Months",{"count":52,"type":53},350,"ESTIMATED","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.\n\nSerotype-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.\n\nAim:\n\nThe 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.\n\nMethods: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.",[57,58],"Pneumonia","Pneumonia - Bacterial",[60,61],"Urinary pneumococcal antigen","Serotype-specific urinary antigen detection","NOT_YET_RECRUITING","2025-09-12",{"date":65,"type":66},"2025-09-18","ACTUAL",{"date":68,"type":53},"2025-10",{"date":70,"type":53},"2027-08",{"name":5,"class":6}]