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
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | |||||||||
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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 |
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Intervention | Other: Urinary antigen detection assay
Screening for Ag level in S. pneumoniae urinary antigen detection assay. | ||||||||
Study Groups/Cohorts |
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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 | 960 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 30, 2021 | ||||||||
Estimated Primary Completion Date | December 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | CASES: Inclusion Criteria:
Exclusion Criteria:
CONTROLS: Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 31 Days to 5 Years (Child) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | University of Colorado, Denver | ||||||||
Study Sponsor | University of Colorado, Denver | ||||||||
Collaborators | Pfizer | ||||||||
Investigators |
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PRS Account | University of Colorado, Denver | ||||||||
Verification Date | April 2021 |