Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05091931
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2021-10-13
Brief Title:
Diagnosis Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
Sponsor:
Pathnostics
Organization:
Pathnostics
Study Overview
Official Title:
A Prospective Observational Cohort Study Comparing the Effects of Guidance UTI vs Culture-based Testing Methods on Antibiotic Prescribing Practices in an Outpatient Setting
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 prospective multicenter comparative cohort observational study is to determine if Guidance UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy adverse events and improves therapeutic accuracy of treatment
Detailed Description:
We propose to conduct a multicenter comparative cohort observational study to determine whether the use of Guidance UTI Clinical Pathway compared with current traditional pathways for urine testing reduces the rates of empiric antibiotic therapy and improves therapeutic accuracy of treatment Comparative outpatient Urology and urogynecology office cohorts will be allocated at an uneven 21 allocation ratio Regardless of arm assignment all outpatient offices have the option to order ANY diagnostic test for suspected UTI this includes urine cultures andor other molecular testing methods including Guidance UTI If a provider in the Guidance Clinical Pathway arm decides to order urine cultures instead of using the Guidance UTI Clinical Pathway those results will also be reported to the site lead though TAT may take up to 72 hours to result per standard culture protocols We will be observing the practices implementation of the Clinical Pathway and reporting infrastructure to provide rapid centralized reporting to the ordering provider allowing for efficient treatment Guidance UTI is currently widely available and all participating outpatient offices regardless of arm will have the option to order this test
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