Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01358799
Other study ID # ACTPS-US10-001
Secondary ID
Status Withdrawn
Phase N/A
First received May 20, 2011
Last updated March 8, 2013
Start date November 2010
Est. completion date January 2012

Study information

Verified date March 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 multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.


Description:

This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years and older
Eligibility Inclusion Criteria:

- The subject is at least 14 years of age at the time of informed consent and is sexually active

- The subject reports symptoms consistent with a suspected STD such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.

- If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam

- 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 IRBapproved waiver for parental consent for minors)

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

- The subject is underage (as defined by the IRB or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)

- The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Device:
APTIMA Assay for Chlamydia trachomatis
APTIMA Assay for Chlamydia trachomatis

Locations

Country Name City State
United States Planned Parenthood Northeast Ohio Akron Ohio
United States University of North Carolina Chapel Hill STD Clinic Chapel Hill North 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 Houston and Southeast Texas Houston Texas
United States Wishard Health Services Department of Pathology Wishard Health Services Indianapolis Indiana
United States Louisianna State University Health Center New Orleans Louisiana

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 Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference approximately one year No
Secondary Positivity Rate Positivity Rate approximately one year No
See also
  Status Clinical Trial Phase
Completed NCT03676816 - Self Sampling for Rapid Turnaround Testing in the Emergency Department N/A
Completed NCT00213018 - Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission Phase 2
Completed NCT00827970 - Randomized Population-Based Study on Chlamydia Trachomatis Screening N/A
Completed NCT01733069 - Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System N/A
Completed NCT00978848 - Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing N/A
Completed NCT02391233 - Multimedia WORTH With Black Drug-Involved Women on Probation N/A
Completed NCT00973466 - Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients N/A
Completed NCT03071510 - Evaluation of the Atlas Genetics io® CTNG System
Recruiting NCT04446611 - Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes N/A
Completed NCT01329588 - Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers Phase 4
Not yet recruiting NCT06216964 - Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study N/A
Terminated NCT02795975 - Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples N/A
Completed NCT00213057 - Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand Phase 1
Completed NCT00207454 - Optimizing Strategies to Improve STD Partner Services Phase 1
Completed NCT00177437 - Home Screening for Chlamydia Surveillance Phase 3
Completed NCT02787109 - Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years Phase 1
Completed NCT01665690 - Washington State Community Expedited Partner Treatment (EPT) Trial Phase 4
Completed NCT02128620 - A Randomized Online Health Experiment for a Safer Youth Sexual Behaviour N/A
Completed NCT00618449 - Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger Phase 4
Recruiting NCT01661985 - Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced Phase 4