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Clinical Study of a Diagnostic Device for NG, TV and CT in Women

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ClinicalTrials.gov Identifier: NCT03852316
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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 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.

Condition or disease Intervention/treatment Phase
Chlamydial Infection Gonococcal Infection Trichomoniasis Device: Click Device Not Applicable

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 population of low Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), or Trichomonas vaginalis (TV) prevalence. Low prevalence sites are defined as sites with a prevalence < / = 2 percent for any of the three targets. Sites with a prevalence higher than 2 percent for any of the three targets will be defined as high prevalence sites. 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, approximately 60 minutes in length. The hypothesis of this study is that Click Diagnostics Sexual Health Test performs substantially equivalent to the NAAT (Nucleic Acid Amplification Test) predicate system, and the identification of each organism (CT, NG, and TV) in self-collected vaginal swabs by women using the Click device will agree with the Patient Infected Status (PIS) with a high sensitivity and specificity. The primary objective is to assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens as compared to 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. The secondary objectives are: 1) to assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens among symptomatic subjects as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP; 2) to assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens among asymptomatic subjects as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pivotal Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : November 24, 2019
Estimated Study Completion Date : November 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Click Device
Each subject (females 14 years of age and older) will perform a self-collection vaginal swab for the Click device and be randomized to a particular order for three vaginal swab collections (performed by Health Care Providers (HCP) as defined by state/local regulatory authorities) for comparator methods. N=1750
Device: Click Device
A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.




Primary Outcome Measures :
  1. The percent sensitivity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP). [ Time Frame: Up to 9 months ]
  2. The percent sensitivity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  3. The percent sensitivity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  4. The percent specificity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  5. The percent specificity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  6. The percent specificity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]

Secondary Outcome Measures :
  1. The percent sensitivity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  2. The percent sensitivity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  3. The percent sensitivity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  4. The percent sensitivity of Click device using self-collected vaginal swabs for detection of Chlamydia trachomatis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  5. The percent sensitivity of Click device using self-collected vaginal swabs for detection of Neisseria gonorrhoeae from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  6. The percent sensitivity of Click device using self-collected vaginal swabs for detection of Trichomonas vaginalis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  7. The percent specificity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  8. The percent specificity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  9. The percent specificity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  10. The percent specificity of Click device using self-collected vaginal swabs for detection of Chlamydia trachomatis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  11. The percent specificity of Click device using self-collected vaginal swabs for detection of Neisseria gonorrhoeae from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  12. The percent specificity of Click device using self-collected vaginal swabs for detection of Trichomonas vaginalis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Female at birth. (Pregnant and breastfeeding women are eligible.)
  3. Age > / = 14 years at the time of enrollment.
  4. Able to read and understand the procedural information provided for the study.
  5. 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 Criteria:

  1. 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.
  2. Enrollment in this study previously.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852316


Contacts
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Contact: Sheldon Morris 16195434761 shmorris@ucsd.edu

Locations
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United States, California
Axis Clinical Trials Terminated
Los Angeles, California, United States, 90036
University of California, San Diego - Antiviral Research Center Terminated
San Diego, California, United States, 92103-8208
San Francisco Department of Public Health - San Francisco City Clinic Terminated
San Francisco, California, United States, 94103-4030
United States, Florida
South Florida Clinical Trials Terminated
Hialeah, Florida, United States, 33016
Florida International University - Student Health Center Recruiting
Miami, Florida, United States, 33199
United States, Illinois
Cook County Health and Hospitals System - Ruth M Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hospital - Medicine - Infectious Diseases Terminated
Baltimore, Maryland, United States, 21205
United States, Mississippi
University of Mississippi - Infectious Diseases Terminated
Jackson, Mississippi, United States, 39202
United States, Nevada
Impact Clinical Trials Recruiting
Las Vegas, Nevada, United States, 89106
United States, Pennsylvania
Philadelphia Department of Public Health - Health Center 1 Recruiting
Philadelphia, Pennsylvania, United States, 19145
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03852316     History of Changes
Other Study ID Numbers: 18-0024
HHSN272201300014I
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: February 20, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Chlamydia trachomatis
Device
Diagnostic
Neisseria gonorrohoeae
Trichomonas vaginalis
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Gonorrhea
Chlamydia Infections
Trichomonas Infections
Protozoan Infections
Parasitic Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Chlamydiaceae Infections