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OpenTrials
Completed

NCT Number: NCT03696303

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

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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Key information

Conditions

Community-Acquired Pneumonia Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections Streptococcus Pneumoniae Infection

Age range

31 day–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Cuilapa, Cuilapa, Santa Rosa Department, Guatemala

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urinary antigen detection assay

Other

Screening for Ag level in S. pneumoniae urinary antigen detection assay.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2018
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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