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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

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ClinicalTrials.gov Identifier: NCT03696303
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : February 18, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Community-acquired Pneumonia Streptococcus Pneumoniae Infection Other: Urinary antigen detection assay

Study Design
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Study Type : Observational
Estimated Enrollment : 960 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cases
Suspected community-acquired bacterial pneumonia
 Other: Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay.
Controls
Healthy children, age-matched to enrolled cases
 Other: Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay.
Controls with URI
Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI)
 Other: Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay.


Outcome Measures
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Primary Outcome Measures :
  1. Urinary antigen detection cut-points for invasive S. pneumoniae disease [ Time Frame: Within 48 hours ]
    To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state


Secondary Outcome Measures :
  1. Detection of S. pneumoniae serotypes using Urinary antigen detection assay [ Time Frame: Within 48 hours ]
    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


Biospecimen Retention:   Samples With DNA
Urine Blood Nasopharyngeal swab samples

Eligibility Criteria
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Ages Eligible for Study:   31 Days to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696303


Contacts
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Contact: Sara R Saporta-Keating, MD 720-777-1084 sara.saporta-keating@childrenscolorado.org
Contact: Daniel Olson, MD 720-724-9558 Daniel.Olson@childrenscolorado.org

Locations
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Guatemala
Hospital Regional Cuilapa Recruiting
Cuilapa, Santa Rosa, Guatemala
Contact: Diva M Calvimontes, MD         
Principal Investigator: Diva M Calvimontes, MD         
Hospital General IGSS Recruiting
Guatemala, Guatemala, 01009
Contact: Fabio Recinos, MD         
Contact: Sonia Perez, MD         
Principal Investigator: Fabio Recinos, MD         
Sub-Investigator: Sonia Perez, MD         
Hospital Roosevelt Recruiting
Guatemala, Guatemala, 01011
Contact: Mario Melgar, MD         
Principal Investigator: Mario A Melgar, MD         
Sponsors and Collaborators
University of Colorado, Denver
Pfizer
Investigators
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Principal Investigator: Edwin Asturias, MD University of Colorado - Anschutz Medical Campus
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03696303    
Other Study ID Numbers: 18-0737
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Streptococcus pneumoniae
Pneumonia
Community-acquired
Pediatric
Urine antigen
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Pneumococcal
Pneumococcal Infections
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Pneumonia, Bacterial