Status:
COMPLETED
Clinical Study of a Diagnostic Device for NG, TV and CT in Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chlamydial Infection
Gonococcal Infection
Eligibility:
FEMALE
14-99 years
Phase:
NA
Brief Summary
This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of ...
Detailed Description
This is a multi-center study with a minimum of three clinical sites across diverse geographical areas in the United States. Approximately one-third of the total number of sites will have a patient pop...
Eligibility Criteria
Inclusion
- Willing and able to give voluntary written informed consent (or the parent/legal guardian will provide parental permission) before any study-related procedure is performed.
- Female at birth. (Pregnant and breastfeeding women are eligible.)
- Age \> / = 14 years at the time of enrollment.
- Able to read and understand the procedural information provided for the study.
- Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a licensed HCP to collect three additional vaginal swabs.
Exclusion
- Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures.
- Enrollment in this study previously.
- Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2019
Estimated Enrollment :
1585 Patients enrolled
Trial Details
Trial ID
NCT03852316
Start Date
February 27 2019
End Date
December 2 2019
Last Update
January 13 2022
Active Locations (10)
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1
Axis Clinical Trials
Los Angeles, California, United States, 90036
2
University of California, San Diego - Antiviral Research Center
San Diego, California, United States, 92103-8208
3
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, United States, 94103-4030
4
South Florida Clinical Trials
Hialeah, Florida, United States, 33016