Detection of Chlamydia (CT) and Gonorrhea (NG)

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055742
• Other study ID #: MBI-01-CTNG
• Secondary ID: Meridian Bioscie
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: December 5, 2017
• Start date: March 1, 2014
• Est. completion date: September 9, 2014

Study information

• Verified date: September 2014
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: September 9, 2014
• Est. primary completion date: September 9, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections
• Gonorrhea

Intervention

Device:
• illumigene CT and NG assays, illumipro-10

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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