Clinical trial NCT02270099: Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Simplex Infections
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 839
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Canoga Park
country: United States
facility: Sherif Khamis MD, Inc
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research
state: California
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research, Inc. (PICR Clinic)
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: New Orleans
country: United States
facility: LSU Health Science Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Science Center - Shreveport
state: Louisiana
city: Towson
country: United States
facility: IRC Clinics
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi Medical Center/Crossroads Clinic (MSDH)
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Burlington
country: United States
facility: Laboratory Corporation of America
state: North Carolina
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Planned Parenthood of Southeastern Pennsylvania
state: Pennsylvania
city: Maryville
country: United States
facility: Geneuity Clinical Research Services
state: Tennessee
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast, Inc.
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: American Regional University Pathologists
state: Utah
Study officials:
affiliation: Hologic, Inc.
name: Rainer Ziermann
role: STUDY_DIRECTOR
References: