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

NCT ID: NCT02738229

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Valacyclovir

Intervention Type: DRUG

control

placebo pill

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Valacyclovir

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Association of Emergency Physicians

INDUSTRY

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jocelyn Gravel

MD, MSc, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

Valtrex for HGS

Identifier Type: -

Identifier Source: org_study_id