Community-acquired PneumoniaNCT03696303
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
An observational study of Community-acquired Pneumonia and Streptococcus Pneumoniae Infection, run by University of Colorado, Denver at 3 sites in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 days to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-acquired Pneumonia, Streptococcus Pneumoniae Infection
- What is being tested?
- Urinary antigen detection assay
- How many people
- 959 participants
- Where
- 3 sitesGuatemala
- Study dates
- 13 Mar 2019to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
3 sites in 1 country.
Guatemala3 sites
Hospital Regional Cuilapa
Cuilapa, Santa Rosa Department
Hospital General IGSS
Guatemala City, 01009
Hospital Roosevelt
Guatemala City, 01011
About this study
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.
- Being tested
- Urinary antigen detection assay
- Keywords
- Streptococcus pneumoniae, Pneumonia, Community-acquired, Pediatric, Urine antigen
- Medical subject headings
- Community-Acquired Pneumonia, Pneumococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary antigen detection assayOther
Screening for Ag level in S. pneumoniae urinary antigen detection assay.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Suspected community-acquired bacterial pneumonia Receives: Other: Urinary antigen detection assay | |
| Controls | Healthy children, age-matched to enrolled cases Receives: Other: Urinary antigen detection assay | |
| Controls with URI | Children 5 years of age or younger with upper respiratory infection (URI) (controls with URI) Receives: Other: Urinary antigen detection assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 48 hours
Secondary outcomes (1)
Detection of S. pneumoniae serotypes using Urinary antigen detection assay
To determine the sensitivity and specificity of the Luminex xMPA pneumococcal UAD in the identification of S. pneumoniae serotypes (PCV13 serotypes) in children with radiologically confirmed CAP
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start13 Mar 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Edwin Asturias, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696303
- Sponsor's protocol ID
- 18-0737
- Status last verified
- May 2022
- First submitted
- 1 Oct 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03696303
- Acronym / sponsor ID
- 18-0737
- Keywords
- Streptococcus pneumoniae, Pneumonia, Community-acquired, Pediatric, Urine antigen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Urinary antigen detection assaySuspected community-acquired bacterial pneumonia |
| Controls | – | Other: Urinary antigen detection assayHealthy children, age-matched to enrolled cases |
| Controls with URI | – | Other: Urinary antigen detection assayChildren 5 years of age or younger with upper respiratory infection (URI) (controls with URI) |
Who may qualify
- Ages
- 31 days to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 5 years of age or younger with either community-acquired pneumonia (cases) or health children (controls).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary antigen detection assayScreening for Ag level in S. pneumoniae urinary antigen detection assay. | Other | Cases, Controls, Controls with URI |
Primary outcome
Urinary antigen detection cut-points for invasive S. pneumoniae disease
Time frame: Within 48 hours
To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state
1 secondary outcome
Detection of S. pneumoniae serotypes using Urinary antigen detection assay
Time frame: Within 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
Related trials for Community-acquired Pneumonia
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Local Antibiotic Delivery for Community Acquired Pneumonia
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Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Asturias, MD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia and Streptococcus Pneumoniae Infection, run by University of Colorado, Denver at 3 sites in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary antigen detection cut-points for invasive S. pneumoniae disease (time frame: Within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.