Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT06369220
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2024-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
Status:
COMPLETED
Status Verified Date:
2025-06
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 CT/NG/MG 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 CT/NG/MG (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 specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 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 participant's 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 participant's 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:
False
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?: