Detection of Chlamydia (CT) and Gonorrhea (NG)

NCT02055742 | Completed

• 2 other identifiers: MBI-01-CTNGMeridian Bioscience, Inc.
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 3

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.

Conditions

Chlamydia; Gonorrhea

Outcome Measures

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

  Testing of each set of subject samples is completed within 60 days of sample collection

  Up to 60 days

Study Arms (1)

Specimen Collection

Device: illumigene CT and NG assays, illumipro-10

Interventions

illumigene CT and NG assays, illumipro-10 DEVICE

Specimen Collection

Eligibility Criteria

• Age: 14 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Symptomatic and asymptomatic subjects at least 14 years of age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (3)

Planned Parenthood of the Rocky Mountains

Aurora, Colorado, 80012, United States

Location

New England Center for Clinical Research

Fall River, Massachusetts, 02720, United States

Location

Planned Parenthood Southeastern PA

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Leftover urine samples

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 5, 2014
• Study Start: March 1, 2014
• Primary Completion: September 9, 2014
• Study Completion: September 9, 2014
• Last Updated: December 7, 2017

Record last verified: 2014-09

Locations

US (3)