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

NCT02738229 | Completed Phase 2 DMC

• 1 other identifier: Valtrex for HGS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpetic Gingivostomatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• duration of fever

  2 weeks

• duration of pain

  2 weeks

• duration of oral lesions

  2 weeks

• global parent satisfaction

  2 weeks

• duration of school or work absence

  2 weeks

Study Arms (2)

Valacyclovir

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

placebo pill

Drug: placebo

Interventions

Valacyclovir DRUG

Valacyclovir

placebo DRUG

control

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Association of Emergency Physicians: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Stomatitis, Herpetic

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCPC

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 14, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

CA (1)