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NCT03852316 · ClinicalTrials.gov registry record · NA
Clinical Study of a Diagnostic Device for NG, TV and CT in Women
A NA study of Chlamydial Infection and Gonococcal Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 1,585
- Enrollment target
- 10
- Study locations
NCT03852316: Completed NA study of Chlamydial Infection and Gonococcal Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03852316 is a NA study of Chlamydial Infection and Gonococcal Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,585 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (13% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03852316, a NA study of Chlamydial Infection and Gonococcal Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 1,585 participants
- Enrollment target
- 10
- Study locations
Study 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 approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit. The primary objective is to assess the performance of the Click device for detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens as compared to Patient Infected Status (PIS) determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
Primary Outcome
The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click resu
Conditions Studied
Interventions
- DEVICE Click Device
Study Locations (10)
California
- Axis Clinical Trials - Los Angeles
- University of California, San Diego - Antiviral Research Center - San Diego
- San Francisco Department of Public Health - San Francisco City Clinic - San Francisco
Florida
- South Florida Clinical Trials - Hialeah
- Florida International University - Student Health Center - Miami
Illinois
- Cook County Health and Hospitals System - Ruth M Rothstein CORE Center - Chicago
Maryland
- Johns Hopkins Hospital - Medicine - Infectious Diseases - Baltimore
Mississippi
- University of Mississippi - Infectious Diseases - Jackson
Nevada
- Impact Clinical Trials - Las Vegas
Pennsylvania
- Philadelphia Department of Public Health - Health Center 1 - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,585 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2019-12-02 |
| Phase | NA |
What the finished NCT03852316 record still lists
NCT03852316 is an interventional study that assigns participants to a tested intervention. Its 1,585 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (13% higher).
The record links to 3 conditions, with Chlamydial Infection appearing as the primary indexed condition, and to 1 intervention - of which Click Device is the first listed.
NCT03852316 lists 10 locations in 7 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT03852316 about?
NCT03852316 is a clinical study titled "Clinical Study of a Diagnostic Device for NG, TV and CT in Women". 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 approximately 9 months after enrollment of the first subject. Female subjects seen at the participat...
What is the current status of trial NCT03852316?
This trial is currently completed. It is a NA study. The enrollment target is 1,585 participants. The study started on 2019-02-27. Estimated completion is 2019-12-02.
What conditions does trial NCT03852316 study?
This clinical trial studies the following conditions: Chlamydial Infection, Gonococcal Infection, Trichomoniasis.
What interventions are being tested in trial NCT03852316?
The interventions under investigation include: Click Device (DEVICE).
Who is sponsoring clinical trial NCT03852316?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03852316 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Maryland, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03852316's enrollment target sits among peer trials
1,585 64th of 2000 higher than 1,937 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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