Detection of Chlamydia (CT) and Gonorrhea (NG)

Completed

Conditions studied: Chlamydia, Gonorrhea

In brief

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.

Key facts

Study ID: NCT02055742
Run by: Meridian Bioscience, Inc.
People needed: 700
Starts: 2014-03-01
Expected to finish: 2014-09-09
Last updated by the study team: 2017-12-07

Who can join

Age: 14 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Planned Parenthood of the Rocky Mountains — Aurora, Colorado, United States
New England Center for Clinical Research — Fall River, Massachusetts, United States
Planned Parenthood Southeastern PA — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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