Status:
UNKNOWN
Identigene STD Test Collection Kit Validation Study
Lead Sponsor:
Identigene
Collaborating Sponsors:
CRI Lifetree Clinical Research
Conditions:
Infection
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testi...
Detailed Description
This is a multicenter study involving asymptomatic and symptomatic subjects who are at risk or suspect possible exposure to CT and/or NG. Approximately five (5) clinics will participate in the study. ...
Eligibility Criteria
Inclusion
- Symptomatic females or males, age 14 or older, who present at a participating clinic with symptoms consistent with Chlamydia trachomatis or Neisseria gonorrhoeae infection, or
- Asymptomatic females or males, age 14 or older, who present at a participating clinic and who suspect that they have CT and/or NG, or are considered at high risk of exposure (e.g., sexual partner that tests positive for CT, or NG, multiple sexual partners, ect.),
- Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
- Individuals who have signed the IRB approved informed consent form.
Exclusion
- Individuals with physical or mental inability that, in the opinion of the investigator can interfere with the subject's ability to follow the Identigene STD Test Collection Kit instructions,
- Individuals who are currently being treated for CT or NG or who are currently receiving antibiotics or have received antibiotics within the last 28 days, and
- Individuals who are suspected of being victims of sexual abuse or nonconsensual contact of a sexual nature within the previous 6 months or who are part of an ongoing sexual abuse legal case.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01471392
Start Date
November 1 2011
End Date
June 1 2014
Last Update
June 3 2013
Active Locations (1)
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1
John Hopkins University
Baltimore, Maryland, United States