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

Herpes Simplex Keratitis Clinical Trial

Official title:

Comparison Between the Sensibility of the Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02045082
• Other study ID #: DR-002-1399, 2012-1649
• Status: Terminated
• Phase: Phase 4
• First received: January 21, 2014
• Last updated: February 25, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex Keratitis
• Keratitis
• Keratitis, Herpetic

Intervention

Procedure:
• Corneal sampling
Slit lamp corneal sampling with a Swab

Locations

Country	Name	City	State
Canada	Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after the initial visit	No
Secondary	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.	1 month after the initial visit	No
Secondary	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	1 month after the initial visit	No