Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

NCT ID: NCT04647630

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Community-acquired Pneumonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CAP

community acquired pneumonia

urine test

Intervention Type DIAGNOSTIC_TEST

test for pneumococcal antigen in urine

Interventions

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urine test

test for pneumococcal antigen in urine

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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To Kin Wang

Honoary Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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K W To

Role: CONTACT

Facility Contacts

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KW To, MBChB

Role: primary

852 26322211

Other Identifiers

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2020.034

Identifier Type: -

Identifier Source: org_study_id

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