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The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

Primary Purpose

Herpes Simplex Keratitis

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Corneal sampling
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Herpes Simplex Keratitis focused on measuring Flocked swab, Traditional fiber swab, Herpes simplex epithelial keratitis, Quantitative PCR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer)

Exclusion Criteria:

  • Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea

Sites / Locations

  • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Flocked swab (Copan 519CS01)

Traditionnal fiber swab (Copan 164KS01)

Arm Description

Sampling of the cornea by the flocked swab

Sampling of the cornea by the traditional finer swab

Outcomes

Primary Outcome Measures

Result of the culture
The result can be Positive or negative for Herpes simplex virus (HSV). Even if the result will be available in less than 1 week by the clinician after the culture, the research team will collect the data 1 month in average after the initial visit.

Secondary Outcome Measures

Time before positivity of the culture
If the culture is positive for Herpes simplex virus, what is the time lapse(in day) before the culture became positive. The research team will collect the data 1 month in average after the initial visit by examining the microbiologic data of the laboratory.
Viral load concentration
Quantitative polymerase chain reaction (PCR) will be on a part of the sampling 1 month after the initial visit. The result will be the concentration of virus in number/ml detected in the sampling

Full Information

First Posted
January 21, 2014
Last Updated
February 25, 2016
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT02045082
Brief Title
The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis
Official Title
Comparison Between the Sensibility of the Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare a corneal sampling realized by a flocked swab (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab 164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes simplex epithelial keratitis will be the primary objective of this study.
Detailed Description
In our center, the flocked swabs became an important tool in the corneal sampling for viral keratitis, replacing rightly or wrongly the former traditional fibers swab. No research was specifically designed to study the corneal taking with these swabs. Nevertheless, numerous reasons would motivate it, because of the peculiarities in ophthalmology: the corneal sampling has to be made with the slit lamp rather than in a macroscopic manner; the corneal lesion are often millimetre-length and confined; the histology of the cornea is unique and compares only imperfectly with other structures of the human body like the nasal mucosa. In these circumstances, the properties of the stalk (rigidity, length) and of its extremity (roughness, textures, absorbance) can influence the quality of the sampling and the final result of the culture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Keratitis
Keywords
Flocked swab, Traditional fiber swab, Herpes simplex epithelial keratitis, Quantitative PCR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flocked swab (Copan 519CS01)
Arm Type
Experimental
Arm Description
Sampling of the cornea by the flocked swab
Arm Title
Traditionnal fiber swab (Copan 164KS01)
Arm Type
Experimental
Arm Description
Sampling of the cornea by the traditional finer swab
Intervention Type
Procedure
Intervention Name(s)
Corneal sampling
Intervention Description
Slit lamp corneal sampling with a Swab
Primary Outcome Measure Information:
Title
Result of the culture
Description
The result can be Positive or negative for Herpes simplex virus (HSV). Even if the result will be available in less than 1 week by the clinician after the culture, the research team will collect the data 1 month in average after the initial visit.
Time Frame
1 month after the initial visit
Secondary Outcome Measure Information:
Title
Time before positivity of the culture
Description
If the culture is positive for Herpes simplex virus, what is the time lapse(in day) before the culture became positive. The research team will collect the data 1 month in average after the initial visit by examining the microbiologic data of the laboratory.
Time Frame
1 month after the initial visit
Title
Viral load concentration
Description
Quantitative polymerase chain reaction (PCR) will be on a part of the sampling 1 month after the initial visit. The result will be the concentration of virus in number/ml detected in the sampling
Time Frame
1 month after the initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer) Exclusion Criteria: Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia-Ann Laughrea, MD, CRMC(C)
Organizational Affiliation
Centre de recherche du CHU de Québec; Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

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