Detection of Chlamydia (CT) and Gonorrhea (NG)
This trial is active, not recruiting.
|Treatment||illumigene ct and ng assays, illumipro-10|
|Sponsor||Meridian Bioscience, Inc.|
|Start date||March 2014|
|End date||December 2016|
|Trial size||700 participants|
|Trial identifier||NCT02055742, MBI-01-CTNG, Meridian Bioscience, Inc.|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aurora, CO||Planned Parenthood of the Rocky Mountains||no longer recruiting|
|Fall River, MA||New England Center for Clinical Research||no longer recruiting|
|Philadelphia, PA||Planned Parenthood Southeastern PA||no longer recruiting|
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
Male or female participants from 14 years up to 89 years old.
- Male or female
- Any ethnicity or race
- Subject >14 and <89 years of age
- Subject who voluntarily gives written informed consent; not applicable for leftover specimens
- Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
- Leftover urine specimens
- Subjects < 14 or >90 years of age
- Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
- Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
- Individuals who have been on antibiotic medications within 10 days.
- Multiple sets of specimens from the same subject at different office visits
- Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
- Frozen archived specimens
|Official title||Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays|
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