Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03931538
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2019-04-25
Brief Title:
Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling MixAR Prospective Study
Sponsor:
Pathnostics
Organization:
Pathnostics
Study Overview
Official Title:
Urinary Tract Infection RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling MixAR
Status:
COMPLETED
Status Verified Date:
2023-08
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:
RapIDMixAR
Brief Summary:
In this protocol investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population
Detailed Description:
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by the previous prospective comparison study Additionally conventional methods are often inadequate in the case of polymicrobial infections More accurate and timely pathogen identification allows for prompt and more targeted treatment with less reliance on empiric therapy and decreased rates of antibiotic therapy changes and retreatment This leads to more favorable patient outcomes and decreases the development of resistant organisms
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?:
False
Is an FDA AA801 Violation?:
None