Detection of Chlamydia (CT) and Gonorrhea (NG)

Completed

• Conditions: Gonorrhea; Chlamydia
• Interventions: Device: illumigene CT and NG assays, illumipro-10

• Registration Number: NCT02055742
• Lead Sponsor: Meridian Bioscience, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Study Start: 2014-03-01
• Status Verified: 2014-09
• Primary Completion: 2014-09-09
• Study Completion: 2014-09-09
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Specimen Collection	illumigene CT and NG assays, illumipro-10	-

Primary Outcome Measures

Name	Time	Method
Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease	Up to 60 days	Testing of each set of subject samples is completed within 60 days of sample collection

Trial Locations

Locations (3)

Planned Parenthood of the Rocky Mountains; 🇺🇸 Aurora, Colorado, United States

Planned Parenthood Southeastern PA; 🇺🇸 Philadelphia, Pennsylvania, United States

New England Center for Clinical Research; 🇺🇸 Fall River, Massachusetts, United States