Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

Study Overview
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Brief Summary
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This prospective case-control study aims to evaluate the utility and establish laboratory thresholds for a multi-serotype urine antigen test for the diagnosis of pneumococcal community acquired pneumonia in children 5 years of age or younger in Guatemala.

Official Title
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Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

Conditions
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Community-acquired Pneumonia, Streptococcus Pneumoniae Infection

Intervention / Treatment
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* Other: Urinary antigen detection assay


Participation Criteria
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Eligibility Criteria
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CASES: Inclusion Criteria: Age older than 1 month (31 days) and up to 71 months and 28 days. Diagnosis of radiologically confirmed pneumonia per WHO criteria in the ED or hospital within 48 hours of hospital admission Signed informed consent by parents or legal guardian to participate in the study Exclusion Criteria: Known immunodeficiency Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder Significant neurological disorder Hospitalization within the previous 30 days for pneumonia or respiratory infection Use of parenteral antibiotics for current illness (leading to diagnosis of pneumonia) Transferred to the study hospital after already being hospitalized at a different location for ≥ 48 hours CONTROLS: Inclusion Criteria: Age 1 to 71 months and signed informed consent by parents or legal guardian Exclusion Criteria: Known immunodeficiency Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder Significant neurological disorder Fever or suspicion of community-acquired pneumonia or other respiratory infectious disease (symptoms of cough, congestion, tachypnea, indrawing, etc.) Hospitalization within the previous 30 days for pneumonia or respiratory infection

Ages Eligible for Study
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Minimum Age: 31 Days
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Suspected community-acquired bacterial pneumonia | Other: Urinary antigen detection assay<br>* Screening for Ag level in S. pneumoniae urinary antigen detection assay.<br>|
| Controls<br>Healthy children, age-matched to enrolled cases | Other: Urinary antigen detection assay<br>* Screening for Ag level in S. pneumoniae urinary antigen detection assay.<br>|
| Controls with URI<br>Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI) | Other: Urinary antigen detection assay<br>* Screening for Ag level in S. pneumoniae urinary antigen detection assay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary antigen detection cut-points for invasive S. pneumoniae disease | To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state | Within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of S. pneumoniae serotypes using Urinary antigen detection assay | To determine the sensitivity and specificity of the Luminex xMPA pneumococcal UAD in the identification of S. pneumoniae serotypes (PCV13 serotypes) in children with radiologically confirmed CAP | Within 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus pneumoniae, Pneumonia, Community-acquired, Pediatric, Urine antigen