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

Community-acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696303
• Other study ID #: 18-0737
• Status: Completed
• Start date: March 13, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Days to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumococcal Infections
• Pneumonia
• Pneumonia, Pneumococcal
• Streptococcus Pneumoniae Infection

Intervention

Other:
• Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay.

Locations

Country	Name	City	State
Guatemala	Hospital Regional Cuilapa	Cuilapa	Santa Rosa
Guatemala	Hospital General IGSS	Guatemala
Guatemala	Hospital Roosevelt	Guatemala

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Pfizer

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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