- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05374018
Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia
March 17, 2026 updated by: To Kin Wang, Chinese University of Hong Kong
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shatin, Hong Kong
- Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
patients admitted for CAP
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Nosocomial pneumonia which is acquired >= 48 hours after hospital admission. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of strep pneumonia
Time Frame: 2 years
|
to determine prevalence
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
January 31, 2026
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (Actual)
May 13, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 17, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC 2020.34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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