Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT01471392
Eligibility Criteria:
Inclusion Criteria:
1. 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
2. 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.),
3. Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
4. Individuals who have signed the IRB approved informed consent form.
Exclusion Criteria:
1. 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,
2. 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
3. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT01471392
Study Brief:
Protocol Section:
NCT01471392