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NCT Number: NCT04647630

Evaluation of Streptococcus Pneumoniae Serotypes Prevalence 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. This is a single center, non-interventional observatory study.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shatin, Hong Kong

Location status: Recruiting

Location contact

KW To, MBChB

CONTACT

852 26322211

KW To, MBChB

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urine test

Diagnostic Test

test for pneumococcal antigen in urine

Primary outcomes

  1. Determine the prevalence of pneumococcal serotypes in adults hospitalized

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

K W To

CONTACT

[email protected]

55699297

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2020
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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