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NCT04647630 Clinical Trial

Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

Community-acquired Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04647630
Other study ID # 2020.034
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Chinese University of Hong Kong
Contact K W To
Phone 55699297
Email tokw617@yahoo.com.hk
Is FDA regulated No
Health authority
Study type Observational

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1800
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• urine test
test for pneumococcal antigen in urine

Locations
Country Name City State
Hong Kong Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK Shatin

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the prevalence of pneumococcal serotypes in adults hospitalized Determine the prevalence of pneumococcal serotypes in adults hospitalized with pneumococcal community acquired pneumonia (CAP) using a specific urine antigen assay 2 years
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