Detection of Chlamydia (CT) and Gonorrhea (NG)

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

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.

Study Overview

• Status: Completed
• Conditions: Chlamydia; Gonorrhea
• Intervention / Treatment: Device: illumigene CT and NG assays, illumipro-10

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Planned Parenthood of the Rocky Mountains
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Planned Parenthood Southeastern PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Symptomatic and asymptomatic subjects at least 14 years of age

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 9, 2014
• Study Completion (Actual): September 9, 2014

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: MBI-01-CTNG; Meridian Bioscience, Inc. (Other Identifier: Meridian Bioscience, Inc.)