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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Suspected community-acquired bacterial pneumonia |
| |
| Controls | Healthy children, age-matched to enrolled cases |
| |
| Controls with URI | Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary antigen detection assay | Other | Screening for Ag level in S. pneumoniae urinary antigen detection assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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CASES:
Inclusion Criteria:
Exclusion Criteria:
CONTROLS:
Inclusion Criteria:
Exclusion Criteria:
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Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).
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| Name | Affiliation | Role |
|---|---|---|
| Edwin Asturias, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Cuilapa | Cuilapa | Santa Rosa Department | Guatemala | |||
| Hospital General IGSS |
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Urine Blood Nasopharyngeal swab samples
| Guatemala City |
| 01009 |
| Guatemala |
| Hospital Roosevelt | Guatemala City | 01011 | Guatemala |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011008 | Pneumococcal Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D008171 | Lung Diseases |
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