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Recruiting NCT04647630

Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

Observational Community-acquired Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: urine test.
Who it may be relevant to
Registry conditions: Community-acquired Pneumonia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test urine test
    test for pneumococcal antigen in urine

Primary outcome measures

  • Determine the prevalence of pneumococcal serotypes in adults hospitalized [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Hong Kong · 1 center
  • Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK — Shatin

Identifiers

NCT: NCT04647630 · 2020.034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗