Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01638637
Other study ID # AGCPS-US11-002
Secondary ID AC2PS-US12-001
Status Completed
Phase N/A
First received February 29, 2012
Last updated October 16, 2013
Start date February 2012
Est. completion date July 2013

Study information

Verified date October 2013
Source Gen-Probe, Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System


Recruitment information / eligibility

Status Completed
Enrollment 1492
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
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 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 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 (female) is asymptomatic and undergoing a routine examination with a pelvic examination

Exclusion Criteria:

- A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Device:
APTIMA Assays; PANTHER System
APTIMA Assays; PANTHER System

Locations

Country Name City State
United States John Hopkins University Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Laboratory Corporation of America Burlington North Carolina
United States University of North Carolina Chapel Hill Chapel Hill North Carolina
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States AGA Clinical Trials Hialeah Florida
United States Planned Parenthood Houston and Southeast Texas Houston Texas
United States Wishard Health Services Indianapolis Indiana
United States Anthony Mills MD Inc. Los Angeles California
United States Molecular Pathology Laboratory Network, Inc. Maryville Tennessee
United States Hennepin County Medical Center Minneapolis Minnesota
United States New England Center for Clinical Research - New Bedford Clinic New Bedford Massachusetts
United States Planned Parenthood Southern New England New Haven Connecticut
United States Louisiana State University Health Sciences New Orleans Louisiana
United States Tidewater Clinical Research, Inc. -Tidewater Physicians for Women Norfolk Virginia
United States Benchmark Research San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease approximately one year No
See also
  Status Clinical Trial Phase
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Completed NCT00381992 - Risk Assessment of Long-Haul Truck Drivers N/A
Completed NCT03294395 - New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea Phase 3
Not yet recruiting NCT06428643 - A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities N/A
Completed NCT03896776 - A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0) N/A
Completed NCT03718806 - Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin Phase 1
Completed NCT04010539 - A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Phase 3
Completed NCT00187902 - Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM N/A
Completed NCT00262106 - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection Phase 3
Completed NCT00207506 - Lay Health Advisors for Sexually Transmitted Disease Prevention Phase 1/Phase 2
Completed NCT04553068 - Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection Phase 3
Active, not recruiting NCT03959527 - Zoliflodacin in Uncomplicated Gonorrhoea Phase 3
Active, not recruiting NCT03980223 - Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men Phase 4
Completed NCT01465607 - Implementation of an Efficacious Intervention for High Risk Women in Mexico N/A
Terminated NCT00120770 - Cellulose Sulfate (CS) Gel and HIV in Nigeria Phase 3
Completed NCT02391233 - Multimedia WORTH With Black Drug-Involved Women on Probation N/A
Recruiting NCT05766904 - Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections Phase 3
Completed NCT04297436 - Gonococcal Vaccine Study in Key Populations in Kenya N/A
Completed NCT03098329 - Check it: A New Approach to Controlling Chlamydia Transmission in Young People N/A
Completed NCT02122094 - Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities N/A