Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647630
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2020-11-23
Brief Title:
Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Prospective Study to Evaluate Streptococcus Pneumoniae Serotypes Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Patients admitted to the medical wards with a provisional diagnosis under pneumoniachest 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None