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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 : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date October 1, 2018
First Posted Date October 4, 2018
Last Update Posted Date January 14, 2019
Estimated Study Start Date March 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03696303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 2, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not yet recruiting
Estimated Enrollment
 (submitted: October 2, 2018)
960
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2019   (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, MD 720-777-1084 sara.saporta-keating@childrenscolorado.org
Contact: Daniel Olson, MD 720-724-9558 Daniel.Olson@childrenscolorado.org
Listed Location Countries Not Provided
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, MD University of Colorado - Anschutz Medical Campus
PRS Account University of Colorado, Denver
Verification Date January 2019