Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610721
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Improving Urinary Tract Infection Diagnosis in Older Patients Validation of a Biomarker Panel UTI-GOLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Urinary Tract Infection Diagnosis in Older Patients Validation of a Biomarker Panel UTI-GOLD
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTI-GOLD
Brief Summary:
The goal of this study is to improve the diagnosis of urinary tract infections UTI in older people 65 years The main research questions are
Research questions
What is the optimal cut-off for each individual biomarker NGALIL-6AZUTIMP2 and CXCL9 and associated sensitivity specificity negative and positive predictive value
sensitivity specificity negative and positive predictive value of a urine leukocyte count cut-off of 200 cellsmicroL validation
What is the optimal combination of biomarkers for UTI diagnosis in older patients
As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1 duration of symptoms 2 complications 3 recurrence of UTI within 2 months and length of hospital stay Next to this the performance of the astrego PA100 will be validated in diagnosing bacteriuria
Participants will
be asked to provide a urine sample once at the beginning of the study
be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks
have their vital parameters temperature and blood pressure measured once at the beginning of the study
Research questions
What is the optimal cut-off for each individual biomarker NGALIL-6AZUTIMP2 and CXCL9 and associated sensitivity specificity negative and positive predictive value
sensitivity specificity negative and positive predictive value of a urine leukocyte count cut-off of 200 cellsmicroL validation
What is the optimal combination of biomarkers for UTI diagnosis in older patients
As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1 duration of symptoms 2 complications 3 recurrence of UTI within 2 months and length of hospital stay Next to this the performance of the astrego PA100 will be validated in diagnosing bacteriuria
Participants will
be asked to provide a urine sample once at the beginning of the study
be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks
have their vital parameters temperature and blood pressure measured once at the beginning of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None