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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03696303

Enrollment

959

Registered

2018-10-04

Start date

2019-03-13

Completion date

2022-03-31

Last updated

2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia, Streptococcus Pneumoniae Infection

Keywords

Streptococcus pneumoniae, Pneumonia, Community-acquired, Pediatric, Urine antigen

Brief summary

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.

Interventions

OTHERUrinary antigen detection assay

Screening for Ag level in S. pneumoniae urinary antigen detection assay.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

31 Days to 5 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Detection of S. pneumoniae serotypes using Urinary antigen detection assay	Within 48 hours	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

Countries

Guatemala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026