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

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

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.

Study Overview

• Status: Completed
• Conditions: Herpetic Gingivostomatitis
• Intervention / Treatment: Drug: placebo; Drug: Valacyclovir

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nathalie Lucas, MD; Phone Number: 514-345-4931; Email: lucasnath@yahoo.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valacyclovir; 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
Placebo Comparator: control; placebo pill	Drug: placebo

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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Canadian Association of Emergency Physicians

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Simplex; Stomatitis; Stomatitis, Herpetic; Anti-Infective Agents; Antiviral Agents; Valacyclovir
• Other Study ID Numbers: Valtrex for HGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED