Clinical Trial: Detection of Chlamydia (CT) and Gonorrhea (NG)

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays

Brief Summary: To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.

Detailed Summary:
Sponsor: Meridian Bioscience, Inc.

Current Primary Outcome: Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease [ Time Frame: Up to 60 days ]

Testing of each set of subject samples is completed within 60 days of sample collection


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Meridian Bioscience, Inc.

Dates:
Date Received: January 31, 2014
Date Started: March 2014
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2014