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

NCT03696303

Last updated date
Study Location
Hospital Regional Cuilapa
Cuilapa, Santa Rosa, , Guatemala
Contact
720-777-1084

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-acquired Pneumonia, Streptococcus Pneumoniae Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
31 + days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Community-acquired Pneumonia, Streptococcus Pneumoniae InfectionDetermination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala
NCT03696303
  1. Cuilapa, Santa Rosa
  2. Guatemala,
  3. Guatemala,
ALL GENDERS
31 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Urine Blood Nasopharyngeal swab samples
Sampling Method Non-Probability Sample
Study Population Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).
Condition
  • Community-acquired Pneumonia
  • Streptococcus Pneumoniae Infection
Intervention Other: Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay.
Study Groups/Cohorts
  • Cases
    Suspected community-acquired bacterial pneumonia
    Intervention: Other: Urinary antigen detection assay
  • Controls
    Healthy children, age-matched to enrolled cases
    Intervention: Other: Urinary antigen detection assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 2, 2018)
960
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 31 Days to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sara R Saporta-Keating, MD720-777-1084[email protected]
Contact: Daniel Olson, MD720-724-9558[email protected]
Listed Location Countries Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number NCT03696303
Other Study ID Numbers 18-0737
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Pfizer
Investigators
Principal Investigator:Edwin Asturias, MDUniversity of Colorado - Anschutz Medical Campus
PRS Account University of Colorado, Denver
Verification Date September 2019