Detection of Chlamydia (CT) and Gonorrhea (NG)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Meridian Bioscience, Inc.
ClinicalTrials.gov Identifier:
NCT02055742
First received: January 31, 2014
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    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 Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Specimen Collection Device: illumigene CT and NG assays, illumipro-10

  Eligibility

Ages Eligible for Study:   14 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Symptomatic and asymptomatic subjects at least 14 years of age

Criteria

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 ClinicalTrials.gov identifier: NCT02055742

Locations
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

No publications provided

Responsible Party: Meridian Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02055742     History of Changes
Other Study ID Numbers: MBI-01-CTNG, Meridian Bioscience, Inc.
Study First Received: January 31, 2014
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Neisseriaceae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial

ClinicalTrials.gov processed this record on October 20, 2014