Overview

This trial is active, not recruiting.

Conditions chlamydia, gonorrhea
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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
illumigene ct and ng assays, illumipro-10

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 14 years up to 89 years old.

Inclusion Criteria: 1. Male or female 2. Any ethnicity or race 3. Subject >14 and <89 years of age 4. Subject who voluntarily gives written informed consent; not applicable for leftover specimens 5. Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG 6. Leftover urine specimens Exclusion Criteria: 1. Subjects < 14 or >90 years of age 2. Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens 3. Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens 4. Individuals who have been on antibiotic medications within 10 days. 5. Multiple sets of specimens from the same subject at different office visits 6. Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert. 7. Frozen archived specimens

Additional Information

Official title Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Meridian Bioscience, Inc..