Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?

Study Overview
=================
Brief Summary
-----------------
Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this are dehydration, pain and hospitalisation. The objective of this randomized controlled trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms associated with acute herpes gingivostomatitis in children. This study will involve 80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days. The primary outcome measure will be the duration (in days) of feeding and/or drinking difficulties.

Official Title
-----------------
Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial

Conditions
-----------------
Herpetic Gingivostomatitis

Intervention / Treatment
-----------------
* Drug: Valacyclovir
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria are : Children from 10 to 28 Kg of weight. The inclusion of participants is based on weight for practical/feasibility reasons because the study medication will be provided in tablet format. The lower limit of 10 kg is to limit to three strata of weight and limit costs engendered by the preparation of medication. Clinical diagnosis of herpetic gingivostomatitis according to the treating physician. This is described by the presence of: Fever (>38.5° rectal, >38° oral) AND Vesicular or ulcerative lesions located in the anterior of the mouth Associated or not with perioral vesicular lesions Visiting the emergency department within the first 96 hours of the disease begin. Exclusion criteria are : Duration of fever > 4 days Hospitalised patients Immunocompromised patients Patients with known hypersensitivity to Valacyclovir Patients with renal failure Children with complete incapacity of oral treatment intake Unable to be contacted for phone follow-up

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valacyclovir<br>Valacyclovir will be given twice a day with following doses according to weight: 10 to 13,9 kg : Valacyclovir 250 mg PO twice per day 14 to 19,9 kg : Valacyclovir 375 mg PO twice per day 20 to 28 kg : Valacyclovir 500 mg PO twice per day | Drug: Valacyclovir<br> <br> |
| Placebo Comparator: control<br>placebo pill | Drug: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of feeding and/or drinking difficulties | This will be defined by the number of days until the participants return to normal feeding and eating according to the parents. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of fever |  | 2 weeks | 
| duration of pain |  | 2 weeks | 
| duration of oral lesions |  | 2 weeks | 
| global parent satisfaction | Likert scale on how satisfied the parents are with the medication. This will be measured during a follow-up survey at 7 and 14 days following randomisation | 2 weeks | 
| duration of school or work absence |  | 2 weeks | 
| utilisation of medical resources | hospitalisation for intra venous hydration, visit to a physician, use of analgesics or other medication. This will be measured during a follow-up survey at 7 and 14 days following randomisation | 2 weeks | 
| adverse side effects |  | 2 weks |