Detection of Chlamydia (CT) and Gonorrhea (NG)

• Sponsor: Meridian Bioscience, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02055742
• Collaborator: (none)
• Enrollment: 700
• Locations: 3
• Duration (Months): 6.3
• Patients Per Site: 233.3
• Patients Per Site Per Month: 37

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chlamydia; Gonorrhea	Device: illumigene CT and NG assays, illumipro-10

Study Design

• Study Type: Observational
• Anticipated Enrollment: 700 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Sep 9, 2014
• Actual Study Completion Date: Sep 9, 2014

Arms and Interventions

Arm	Intervention/Treatment
Specimen Collection	Device: illumigene CT and NG assays, illumipro-10

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of the Rocky Mountains	Aurora	Colorado	United States	80012
2	New England Center for Clinical Research	Fall River	Massachusetts	United States	02720
3	Planned Parenthood Southeastern PA	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Meridian Bioscience, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meridian Bioscience, Inc.
• ClinicalTrials.gov Identifier: NCT02055742
• Other Study ID Numbers: MBI-01-CTNG; Meridian Bioscience, Inc.
• First Posted: Feb 5, 2014
• Last Update Posted: Dec 7, 2017
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Chlamydia Infections; Gonorrhea

Study Results

No Results Posted as of Dec 7, 2017