Gonorrhea Clinical Trial
Official title:
Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays
Verified date | August 2017 |
Source | Gen-Probe, Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
Status | Terminated |
Enrollment | 1336 |
Est. completion date | |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal intercourse within the past 12 months) - The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board [IRB]-approved waiver for parental consent for minors) In addition, the subject must meet at least one of the following criteria: - The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort - Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s) - Subject is asymptomatic and undergoing screening evaluation for possible STIs - Subject is asymptomatic and undergoing a routine examination with a pelvic examination Exclusion Criteria: - The subject took antibiotic medications within the last 21 days - Subject already participated in this study - Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial - Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled |
Country | Name | City | State |
---|---|---|---|
United States | John Hopkins University | Baltimore | Maryland |
United States | Infectious Diseases STD Program University of Alabama at Birmingham | Birmingham | Alabama |
United States | University of North Carolina Chapel Hill | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology | Cincinnati | Ohio |
United States | New England Center for Clinical Research | Fall River | Massachusetts |
United States | Planned Parenthood Gulf Coast | Houston | Texas |
United States | The Jackson Clinic | Jackson | Tennessee |
United States | Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease | New Orleans | Louisiana |
United States | Tidewater Clinical Research | Norfolk | Virginia |
United States | Healthcare Clinical Data | North Miami | Florida |
United States | Planned Parenthood Southeastern Pennsylvania | Philadelphia | Pennsylvania |
United States | Medical Center for Clinical Research | San Diego | California |
United States | Mount Vernon Clinical Research | Sandy Springs | Georgia |
Lead Sponsor | Collaborator |
---|---|
Gen-Probe, Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease | approximately one year |
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