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Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

Prospective Study to Evaluate Streptococcus Pneumoniae Serotypes Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04647630
Enrollment
1800
Registered
2020-12-01
Start date
2021-01-01
Completion date
2025-12-31
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Brief 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. This is a single center, non-interventional observatory study.

Detailed description

Patients admitted to the medical wards with a provisional diagnosis under pneumonia,chest infection or fever will be screened by research assistants. Patients eligible with the inclusion criteria will be recruited into the study. Informed consent will be signed for those patients willing to participate in the study. Patient will be asked to save approximately 40 ml of urine. The urine sample will be processed in local laboratory and shipped out to a commercial lab for detection of any pneumococcal pneumoniae, and if present, serotyping will be performed at the same time using the same urine sample by urinary antigen assay. Meanwhile patients will be managed as usual by their clinical teams. Investigations and treatment will be offered by the clinical team as deemed necessary. The study team will only perform collection of urine and will not interfere the clinical management of the patients. Positive results would be informed to the clinical teams for the appropriate action.

Interventions

DIAGNOSTIC_TESTurine test

test for pneumococcal antigen in urine

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted with signs and symptoms suggestive of pneumonia

Exclusion criteria

* 1\. Nosocomial pneumonia which is acquired \>= 48 hours after hospital admission. 2. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.

Design outcomes

Primary

MeasureTime frameDescription
Determine the prevalence of pneumococcal serotypes in adults hospitalized2 yearsDetermine the prevalence of pneumococcal serotypes in adults hospitalized with pneumococcal community acquired pneumonia (CAP) using a specific urine antigen assay

Countries

Hong Kong

Contacts

Primary ContactK W To
tokw617@yahoo.com.hk55699297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026