Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05385536
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-05-12
Brief Title:
Evaluating UTI Outcomes in at Risk Populations
Sponsor:
Pathnostics
Organization:
Pathnostics
Study Overview
Official Title:
Evaluating UTI Outcomes in at Risk Populations
Status:
COMPLETED
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:
At Risk
Brief Summary:
This is a multicenter observational comparative cohort study to evaluate the UTI related adverse event rates between Guidance UTI clinical pathway versus the current traditional clinical pathways for urine testing
Detailed Description:
Clinical sites will be identified by an internal database prepared by the sponsor based on previous experience with the sites Study allocation will based on their current usage of Guidance UTI and the reporting pathway described above will be implemented Those who currently routinely use Guidance UTI testing procedures will be over sampled 21 over those who do not routinely use Guidance UTI Larger clinical care systems with multiple care sites may have locations allocated to different cohort The basis for cohort allocation will be based on the availability and willingness of providers in these markets to implement infrastructure for collecting and reporting of Guidance UTI clinical pathway The comparative cluster cohort will be selected from select geographies within the US based on size of general population served matching to those enrolled in the Guidance UTI clinical pathway
The method of patient care and management eg test ordering and antimicrobial initiation is at the discretion of the treating physicians Specimens collected for suspected UTI may be sent to Pathnostics for standard bacterial identification and sensitivities Guidance UTI can only be performed at Pathnostics whereas urine cultures may be performed at any lab Trained and experienced clinical lab scientists at Pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have
The method of patient care and management eg test ordering and antimicrobial initiation is at the discretion of the treating physicians Specimens collected for suspected UTI may be sent to Pathnostics for standard bacterial identification and sensitivities Guidance UTI can only be performed at Pathnostics whereas urine cultures may be performed at any lab Trained and experienced clinical lab scientists at Pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have
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