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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

: Cases
Suspected community-acquired bacterial pneumonia
: Controls
Healthy children, age-matched to enrolled cases

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

960

Original Estimated Enrollment ^ICMJE

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 ^ICMJE

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

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:

Responsible Party

，

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Edwin Asturias, MD University of Colorado - Anschutz Medical Campus

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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