Clinical trial NCT03696303: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-acquired Pneumonia
Streptococcus Pneumoniae Infection
Keywords: Streptococcus pneumoniae
Pneumonia
Community-acquired
Pediatric
Urine antigen
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-10-04
Enrollment: 959
Sex: ALL
Minimum age (years): 31
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).

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.


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

Primary outcomes:
measure: Urinary antigen detection cut-points for invasive S. pneumoniae disease
timeFrame: Within 48 hours
Secondary outcomes:
measure: Detection of S. pneumoniae serotypes using Urinary antigen detection assay
timeFrame: Within 48 hours
Other outcomes:
Locations:
city: Cuilapa
country: Guatemala
facility: Hospital Regional Cuilapa
state: Santa Rosa
city: Guatemala
country: Guatemala
facility: Hospital General IGSS
city: Guatemala
country: Guatemala
facility: Hospital Roosevelt
Study officials:
affiliation: University of Colorado, Denver
name: Edwin Asturias, MD
role: PRINCIPAL_INVESTIGATOR
References: