Herpes Simplex InfectionsNCT02270099
Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
An observational study of Herpes Simplex Infections, run by Hologic, Inc. at 22 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Herpes Simplex Infections
- How many people
- 839 participants
- Where
- 22 sitesUnited States
- Study dates
- Dec 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Perimeter Institute for Clinical Research, Inc. (PICR Clinic)
Atlanta, Georgia, 30338
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Advanced Clinical Research
Boise, Idaho, 83642
Laboratory Corporation of America
Burlington, North Carolina, 27215
Sherif Khamis MD, Inc
Canoga Park, California, 91303
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80206
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, 77023
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Mississippi Medical Center/Crossroads Clinic (MSDH)
Jackson, Mississippi, 39216
Mills Clinical Research
Los Angeles, California, 90069
Geneuity Clinical Research Services
Maryville, Tennessee, 37804
Yale School of Medicine
New Haven, Connecticut, 06510
LSU Health Science Center
New Orleans, Louisiana, 70112
Quality Clinical Research Inc.
Omaha, Nebraska, 68114
Planned Parenthood of Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
Westover Heights Clinic
Portland, Oregon, 97210
Rochester Clinical Research, Inc.
Rochester, New York, 14609
American Regional University Pathologists
Salt Lake City, Utah, 84108
LSU Health Science Center - Shreveport
Shreveport, Louisiana, 71103
IRC Clinics
Towson, Maryland, 21204
Center for Clinical Studies
Webster, Texas, 77598
About this study
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)
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.
- Conditions
- Herpes Simplex Infections
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with suspected HSV Lesions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Ziermann, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270099
- Sponsor's protocol ID
- A10921-HSVPS-CSP-01
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02270099
- Acronym / sponsor ID
- A10921-HSVPS-CSP-01
- Conditions
- Herpes Simplex Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with suspected HSV Lesions | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Ziermann study director
Hologic, Inc.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex Infections, run by Hologic, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sensitivity and specificity of the Aptima HSV 1 & 2 Assay on Panther (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.