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

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia; Streptococcus Pneumoniae Infection
• Intervention / Treatment: Other: Urinary antigen detection assay

• Study Type: Observational
• Enrollment (Actual): 959

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala, Guatemala, 01011
    • Hospital Roosevelt
  • Guatemala, Guatemala, 01009
    • Hospital General IGSS
  • Santa Rosa
    • Cuilapa, Santa Rosa, Guatemala
      • Hospital Regional Cuilapa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Pfizer
• Investigators: Principal Investigator: Edwin Asturias, MD, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Pneumonia; Pediatric; Streptococcus pneumoniae; Community-acquired; Urine antigen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: 18-0737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No