NCT04647630

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

5 years

First QC Date

November 23, 2020

Last Update Submit

February 10, 2025

Conditions

Community-acquired Pneumonia

Outcome Measures

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

    2 years

Study Arms (1)

CAP

community acquired pneumonia

Diagnostic Test: urine test

Interventions

urine testDIAGNOSTIC_TEST

test for pneumococcal antigen in urine

CAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults hospitalized with pneumococcal community acquired pneumonia (CAP)

You may qualify if:

  • Admitted with signs and symptoms suggestive of pneumonia

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative Techniques

Central Study Contacts

K W To

CONTACT

55699297tokw617@yahoo.com.hk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honoary Clinical Associate Professor

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

HK(1)