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

Herpetic Gingivostomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738229
• Other study ID #: Valtrex for HGS
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: December 2022

Study information

• Verified date: April 2023
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpetic Gingivostomatitis
• Stomatitis

Intervention

Drug:
• Valacyclovir

• placebo

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Canadian Association of Emergency Physicians

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	duration of fever		2 weeks
Secondary	duration of pain		2 weeks
Secondary	duration of oral lesions		2 weeks
Secondary	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
Secondary	duration of school or work absence		2 weeks
Secondary	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
Secondary	adverse side effects		2 weks