NCT03696303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
959

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 13, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

October 1, 2018

Last Update Submit

May 2, 2022

Conditions

Community-acquired PneumoniaStreptococcus Pneumoniae Infection

Keywords

Streptococcus pneumoniaePneumoniaCommunity-acquiredPediatricUrine antigen

Outcome Measures

Primary Outcomes (1)

  • Urinary antigen detection cut-points for invasive S. pneumoniae disease

    To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state

    Within 48 hours

Secondary Outcomes (1)

  • Detection of S. pneumoniae serotypes using Urinary antigen detection assay

    Within 48 hours

Study Arms (3)

Cases

Suspected community-acquired bacterial pneumonia

Other: Urinary antigen detection assay

Controls

Healthy children, age-matched to enrolled cases

Other: Urinary antigen detection assay

Controls with URI

Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI)

Other: Urinary antigen detection assay

Interventions

Urinary antigen detection assayOTHER

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

CasesControlsControls with URI

Eligibility Criteria

Age31 Days - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Age 1 to 71 months and signed informed consent by parents or legal guardian
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Regional Cuilapa

Cuilapa, Santa Rosa Department, Guatemala

Location

Hospital General IGSS

Guatemala City, 01009, Guatemala

Location

Hospital Roosevelt

Guatemala City, 01011, Guatemala

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine Blood Nasopharyngeal swab samples

MeSH Terms

Conditions

Community-Acquired PneumoniaPneumococcal InfectionsPneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesLung Diseases

Study Officials

  • Edwin Asturias, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 4, 2018

Study Start

March 13, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

GU(3)