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RecruitingNCT04647630Updated Feb 12, 2025

Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit

An observational study in Community-acquired Pneumonia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2021; still recruiting 5 years 10 months later.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,800
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Community-acquired Pneumonia
03

In context

Community-Acquired Pneumonia

325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 650 across 111 observational studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,455 studies on the registry; 475 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adults hospitalized with pneumococcal community acquired pneumonia (CAP)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admitted with signs and symptoms suggestive of pneumonia

Exclusion criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • CAP

    community acquired pneumonia

    Diagnostic Test: urine test

Interventions

  • Diagnostic testurine test

    test for pneumococcal antigen in urine

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
    Shatin, Hong Kong
    Recruiting
    • KW To, MBChB · Contact852 26322211
    • KW To, MBChB · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2025, 59 months after the start.

Of 38 observational studies under Community-Acquired Pneumonia, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's planned 59 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2020
First posted
Dec 1, 2020
StartActual
Jan 1, 2021
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04647630
Responsible party
To Kin Wang (Honoary Clinical Associate Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Dec 1, 2020
Start date
Jan 1, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 12, 2025

Study contacts

K W To
Contact
tokw617@yahoo.com.hk
55699297

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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