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
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 |
Verified date | May 2022 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Guatemala | Hospital Regional Cuilapa | Cuilapa | Santa Rosa |
Guatemala | Hospital General IGSS | Guatemala | |
Guatemala | Hospital Roosevelt | Guatemala |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Pfizer |
Guatemala,
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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