Urinary Antigen Test for Stretococcus Pneumoniae Serotype... | NCT05374018

Studies
Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia

NCT05374018

Sponsor

Chinese University of Hong Kong

Status

Active, not recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

1,800Estimated

Phase

Not provided

Conditions

Pneumonia

Interventions

urinary kit for pneumococcus antigen assay

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Jan 31, 2026Actual

Completion Date

Jun 30, 2027Estimated

First Submitted Date

May 10, 2022

First Submission Date that Met QC Criteria

May 10, 2022

First Posted Date

May 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
urinary kit for pneumococcus antigen assay	Diagnostic Test	urine test for detection of pneumococcus antigen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of strep pneumonia	to determine prevalence	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted with signs and symptoms suggestive of pneumonia which include one or more of the followings:

fever
CXR changes with consolidation, increased alveolar shadowing or hazziness
respiratory symptoms like increase shortness of breath, cough with sputum Raised inflammatory markers suggesting of bacterial infection with either increased white cell count or C-reactive protein, or both

Exclusion Criteria:

Nosocomial pneumonia which is acquired >= 48 hours after hospital admission. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients admitted for CAP

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK		Shatin			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided