Objective: To determine the incidence of asymptomatic oral and corneal HSV-1 shedding.
ID
Source
Brief title
Condition
- Eye disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Proportion of HSV-1 DNA positive oral and
corneal samples.
Secondary outcome
Not applicable
Background summary
Rationale: HSV-1 infections are a leading cause of corneal disease. Therapeutic
intervention of herpetic keratitis involves systemic or topical treatment with
antivirals. Long-term antiviral therapy may, however, increase the risk of
therapy-resistant HSV-1 strains and consequently poor visual outcome. It is
conjectured that asymptomatic, corneal viral shedding may serve 1) as a
substitute outcome parameter for efficacy of treatment, and 2) as a diagnostic
tool to determine the antiviral susceptibility profile.
Study objective
Objective: To determine the incidence of asymptomatic oral and corneal HSV-1
shedding.
Study design
Study design: Prospective, observational.
Study burden and risks
With respect to their health care, subjects do not benefit from participation,
risks are considered to be mild/moderate. As the burden of participation is
substantial, participants will be financially compensated.
'Gravendijkwal 230 Ee1720a
Roterdam 3015GE
NL
'Gravendijkwal 230 Ee1720a
Roterdam 3015GE
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years.
- Informed consent.
- Immunecompetent individual.
- Positive HSV-1 infection status
- No symptomatic ocular HSV-1 disease during 3 months preceding first study
sampling.
- No anti-HSV therapy during 1 month preceding first study sampling.
- No immunesuppressive drugs during the 3 months preceding first study sampling.
- No previous keratoplasty
Exclusion criteria
- Individual not able to adhere to bi-daily oral and corneal sampling for 30
consecutive days.
- Individuals wearing contact lenses
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70957.078.19 |