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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

959 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-13

Study Completion Date

2022-03-31

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.

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Detailed Description

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Conditions

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Community-acquired Pneumonia Streptococcus Pneumoniae Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Suspected community-acquired bacterial pneumonia

Urinary antigen detection assay

Intervention Type OTHER

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

Controls

Healthy children, age-matched to enrolled cases

Urinary antigen detection assay

Intervention Type OTHER

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)

Urinary antigen detection assay

Intervention Type OTHER

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

Interventions

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Urinary antigen detection assay

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
* 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:

* 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

Minimum Eligible Age

31 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes