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OpenTrials
Completed

NCT Number: NCT02055742

Detection of Chlamydia (CT) and Gonorrhea (NG)

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.

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Key information

Conditions

Chlamydia Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

14 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Planned Parenthood of the Rocky Mountains, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Any ethnicity or race
  • Subject >14 and <89 years of age
  • Subject who voluntarily gives written informed consent; not applicable for leftover specimens
  • Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
  • Leftover urine specimens

Exclusion criteria

  • Subjects < 14 or >90 years of age
  • Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
  • Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
  • Individuals who have been on antibiotic medications within 10 days.
  • Multiple sets of specimens from the same subject at different office visits
  • Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
  • Frozen archived specimens

Treatment and study plan

illumigene CT and NG assays, illumipro-10

Device

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2014
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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