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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Streptococcus Pneumoniae Infection; Community-acquired Pneumonia

Treatments: Other: Urinary antigen detection assay

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03696303

18-0737

Details and patient eligibility

About

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.

Enrollment: 959 patients

Sex: All

Ages: 31 days to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

959 participants in 3 patient groups

Cases

Description:

Suspected community-acquired bacterial pneumonia

Treatment:

Other: Urinary antigen detection assay

Controls

Description:

Healthy children, age-matched to enrolled cases

Treatment:

Other: Urinary antigen detection assay

Controls with URI

Description:

Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI)

Treatment:

Other: Urinary antigen detection assay