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

Primary Purpose

Herpetic Gingivostomatitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Valacyclovir
placebo
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpetic Gingivostomatitis

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valacyclovir

control

Arm Description

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

placebo pill

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

duration of fever
duration of pain
duration of oral lesions
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
duration of school or work absence
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
adverse side effects

Full Information

First Posted
April 5, 2016
Last Updated
April 10, 2023
Sponsor
St. Justine's Hospital
Collaborators
Canadian Association of Emergency Physicians
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1. Study Identification

Unique Protocol Identification Number
NCT02738229
Brief Title
Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?
Official Title
Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Canadian Association of Emergency Physicians

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpetic Gingivostomatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valacyclovir
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
placebo pill
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Duration of feeding and/or drinking difficulties
Description
This will be defined by the number of days until the participants return to normal feeding and eating according to the parents.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
duration of fever
Time Frame
2 weeks
Title
duration of pain
Time Frame
2 weeks
Title
duration of oral lesions
Time Frame
2 weeks
Title
global parent satisfaction
Description
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
Time Frame
2 weeks
Title
duration of school or work absence
Time Frame
2 weeks
Title
utilisation of medical resources
Description
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
Time Frame
2 weeks
Title
adverse side effects
Time Frame
2 weks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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