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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 | Clinical Trials | Clareo Health

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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

NCT03696303•University of Colorado, Denver

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•CASES:
•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
•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
•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:
•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
+2 more criteria

Locations (3)

Hospital Regional Cuilapa

Cuilapa, Santa Rosa Department, Guatemala

Hospital General IGSS

Guatemala City, Guatemala

Hospital Roosevelt

Guatemala City, Guatemala

Key Dates

Start Date

March 13, 2019

Primary Completion Date

March 31, 2022

Completion Date

March 31, 2022

Last Updated

May 4, 2022

Enrollment

959

ACTUAL participants

Conditions

Community-acquired PneumoniaStreptococcus Pneumoniae Infection

Interventions

Urinary antigen detection assay

OTHER

The Fever Clinic Acute Respiratory Cohort

NCT07278700

Acute Respiratory InfectionsFebrile Illnesses+3 more

View study

RECRUITINGPHASE4

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

NCT06295120

Community-acquired Pneumonia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

The Fever Clinic Acute Respiratory Cohort

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants

Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management