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Detection of Chlamydia (CT) and Gonorrhea (NG)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Meridian Bioscience, Inc..
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Meridian Bioscience, Inc. Identifier:
First received: January 31, 2014
Last updated: September 13, 2016
Last verified: September 2014
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 Intervention
Chlamydia Gonorrhea Device: illumigene CT and NG assays, illumipro-10

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays

Resource links provided by NLM:

Further study details as provided by Meridian Bioscience, Inc.:

Primary Outcome Measures:
  • 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 ]
    Testing of each set of subject samples is completed within 60 days of sample collection

Biospecimen Retention:   Samples With DNA
Leftover urine samples

Estimated Enrollment: 700
Study Start Date: March 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Specimen Collection Device: illumigene CT and NG assays, illumipro-10


Ages Eligible for Study:   14 Years to 89 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Symptomatic and asymptomatic subjects at least 14 years of age

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02055742

United States, Colorado
Planned Parenthood of the Rocky Mountains
Aurora, Colorado, United States, 80012
United States, Massachusetts
New England Center for Clinical Research
Fall River, Massachusetts, United States, 02720
United States, Pennsylvania
Planned Parenthood Southeastern PA
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Meridian Bioscience, Inc.
  More Information

Responsible Party: Meridian Bioscience, Inc. Identifier: NCT02055742     History of Changes
Other Study ID Numbers: MBI-01-CTNG
Meridian Bioscience, Inc. ( Other Identifier: Meridian Bioscience, Inc. )
Study First Received: January 31, 2014
Last Updated: September 13, 2016

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections processed this record on August 21, 2017