Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects

August 10, 2017 updated by: Hologic, Inc.

Clinical Evaluation of the Aptima® Herpes Simplex Viruses 1 & 2 Assay on the Panther® System in Swab Specimens From Symptomatic Subjects Presenting With a Suspected Herpes Lesion(s)

This clinical performance study is being conducted to evaluate the performance of the Aptima Herpes Simplex Viruses 1 & 2 assay for detection of herpes simplex virus (HSV) type 1 (HSV-1) and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV lesions. Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima swab collection kits will be evaluated.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

839

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
    • California
      • Canoga Park, California, United States, 91303
        • Sherif Khamis MD, Inc
      • Los Angeles, California, United States, 90069
        • Mills Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80206
        • Planned Parenthood of the Rocky Mountains
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Perimeter Institute for Clinical Research, Inc. (PICR Clinic)
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Science Center
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Science Center - Shreveport
    • Maryland
      • Towson, Maryland, United States, 21204
        • IRC Clinics
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center/Crossroads Clinic (MSDH)
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research Inc.
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Laboratory Corporation of America
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Planned Parenthood of Southeastern Pennsylvania
    • Tennessee
      • Maryville, Tennessee, United States, 37804
        • Geneuity Clinical Research Services
    • Texas
      • Houston, Texas, United States, 77023
        • Planned Parenthood Gulf Coast, Inc.
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • American Regional University Pathologists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects attending participating US collection sites and presenting with suspected HSV lesion(s) will be eligible for the study. Sites may include family planning, general practice, dermatology, research, sexually transmitted infection, adolescent, and public health clinics. There are no age restrictions for this study.

Description

Inclusion Criteria:

  • The subject has at least 1 active lesion (lesion with exudates and cellular material; eg, vesicle, ulcer) that is suspected to be caused by HSV (as determined by the clinician)
  • The subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors)

Exclusion Criteria:

  • The subject has only HSV lesions without exudates and cellular material
  • The subject used a topical or oral antiviral medication used to treat HSV within 21 days of enrollment
  • Subject already participated in this study
  • Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study
  • Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects with suspected HSV Lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther
Time Frame: 1 day
Sensitivity and specificity of the Aptima HSV 1 & 2 assay will be determined by comparing assay results to results from a reference method representing the true infected status of the subjects. Sensitivity will be reported as the percentage of subjects with an HSV infection who test positive by the Aptima HSV 1 & 2 assay. Specificity will be reported as the percentage of subjects without an HSV infection who test negative by the Aptima HSV 1 & 2 assay.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Investigators

  • Study Director: Rainer Ziermann, Hologic, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A10921-HSVPS-CSP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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