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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03696303
Other study ID # 18-0737
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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