PneumoniaNCT05374018
Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia
An observational study of Pneumonia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- urinary kit for pneumococcus antigen assay
- How many people
- 1,800 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients admitted for CAP
Who may be able to join
- Admitted with signs and symptoms suggestive of pneumonia which include one or more of the followings:
- fever
- CXR changes with consolidation, increased alveolar shadowing or hazziness
- respiratory symptoms like increase shortness of breath, cough with sputum Raised inflammatory markers suggesting of bacterial infection with either increased white cell count or C-reactive protein, or both
Who cannot join
- Nosocomial pneumonia which is acquired >= 48 hours after hospital admission. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Shatin
About this study
Official title: Prospective Study to Evaluate Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit
This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay
- Conditions
- Pneumonia
- Being tested
- urinary kit for pneumococcus antigen assay
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary kit for pneumococcus antigen assayDiagnostic test
urine test for detection of pneumococcus antigen
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of strep pneumonia
to determine prevalence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Dec 2021
- Primary completion31 Jan 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 only
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, To Kin Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374018
- Sponsor's protocol ID
- CREC 2020.34
- Status last verified
- Mar 2026
- First submitted
- 10 May 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit
- ClinicalTrials.gov ID
- NCT05374018
- Acronym / sponsor ID
- CREC 2020.34
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 May 2022 (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 is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients admitted for CAP
Key inclusion criteria (4 listed)
- Admitted with signs and symptoms suggestive of pneumonia which include one or more of the followings:
- fever
- CXR changes with consolidation, increased alveolar shadowing or hazziness
- respiratory symptoms like increase shortness of breath, cough with sputum Raised inflammatory markers suggesting of bacterial infection with either increased white cell count or C-reactive protein, or both
Key exclusion criteria (1 listed)
- Nosocomial pneumonia which is acquired >= 48 hours after hospital admission. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.
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 kit for pneumococcus antigen assayurine test for detection of pneumococcus antigen | Diagnostic test | – |
Primary outcome
prevalence of strep pneumonia
Time frame: 2 years
to determine prevalence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
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?
prevalence of strep pneumonia (time frame: 2 years). 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 18 Mar 2026.