Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369220
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-12
Brief Title:
A Study of the Cobas Liat CTNGMG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Study of the Clinical Utility of Point of Care Cobas Liat CTNGMG Nucleic Acid Test Versus Current Standard Practice
Status:
RECRUITING
Status Verified Date:
2024-10
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 study is designed to assess the comparative clinical utility of the point of care cobas liat CTNGMG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis CT Neisseria gonorrhoeae NG and Mycoplasma genitalium MG
Detailed Description:
The study is designed as a block randomized controlled 2-arm prospective study The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections STIs-participants who have known contact with CTNGMG including participants who report knowledge or suspicion of STI exposure despite the uncertainty of the specific STI pathogen or contact testing results or participants with symptoms suggestive of STI-to participate in this study Participants who give consent will provide demographic information and urogenital specimens for CTNGMG testing on the cobas liat system and for external laboratory-polymerase chain reaction EL-PCR testing Participants will be randomized in a 11 ratio in blocks of multiples of 2 stratified by the site to either of the following arms
Standard of Care SOC
Point of Care POC
In both arms the clinician will see and evaluate the participant and will complete a standardized form known as a patient management plan PMP at the conclusion of the participants encounter The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions whereas the SOC arm will not receive POC test results
Standard of Care SOC
Point of Care POC
In both arms the clinician will see and evaluate the participant and will complete a standardized form known as a patient management plan PMP at the conclusion of the participants encounter The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions whereas the SOC arm will not receive POC test results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None