Clinical trial NCT01728103: Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
Official title: Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chlamydia Infections
Gonorrhea
Trichomonas Infections
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 1336
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Infectious Diseases STD Program University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: North Miami
country: United States
facility: Healthcare Clinical Data
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
state: Ohio
city: Philadelphia
country: United States
facility: Planned Parenthood Southeastern Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
city: Norfolk
country: United States
facility: Tidewater Clinical Research
state: Virginia
Study officials:
affiliation: Gen-Probe, Incorporated
name: Renee Wait
role: STUDY_DIRECTOR
References: