Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

Recruiting

• Conditions: Community-acquired Pneumonia
• Interventions: Diagnostic Test: urine test

• Registration Number: NCT04647630
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Study Start: 2021-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAP	urine test	community acquired pneumonia

Primary Outcome Measures

Name	Time	Method
Determine the prevalence of pneumococcal serotypes in adults hospitalized	2 years	Determine the prevalence of pneumococcal serotypes in adults hospitalized with pneumococcal community acquired pneumonia (CAP) using a specific urine antigen assay

Trial Locations

Locations (1)

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK; 🇭🇰 Shatin, Hong Kong