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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Adult Trials: 18+ Years
- 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, 2020 | ||||||||
| Estimated Primary Completion Date | December 30, 2020 (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 | November 2020 | ||||||||