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

Herpes Simplex Infections Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270099
• Other study ID #: A10921-HSVPS-CSP-01
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: August 10, 2017
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: June 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex Infections

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther	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