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

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ClinicalTrials.gov Identifier: NCT02738229
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Canadian Association of Emergency Physicians
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital

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.

Condition or disease Intervention/treatment Phase
Herpetic Gingivostomatitis Drug: Valacyclovir Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Duration of feeding and/or drinking difficulties [ Time Frame: 2 weeks ]
    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 :
  1. duration of fever [ Time Frame: 2 weeks ]
  2. duration of pain [ Time Frame: 2 weeks ]
  3. duration of oral lesions [ Time Frame: 2 weeks ]
  4. global parent satisfaction [ Time Frame: 2 weeks ]
    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

  5. duration of school or work absence [ Time Frame: 2 weeks ]
  6. utilisation of medical resources [ Time Frame: 2 weeks ]
    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

  7. adverse side effects [ Time Frame: 2 weks ]


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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738229


Contacts
Contact: Nathalie Lucas, MD 514-345-4931 lucasnath@yahoo.com
Contact: Jocelyn Gravel, MD 514-345-4931 ext 2559 graveljocelyn@hotmail.com

Locations
Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Jocelyn Gravel, MD    514-345-4931 ext 2559    graveljocelyn@hotmail.com   
Contact: Weill Olivia, MD    514-345-4931    weill.olivia@gmail.com   
Sub-Investigator: Jocelyn Gravel, MD         
Principal Investigator: Lucas Nathalie, MD         
Principal Investigator: Renaud Christian, MD         
Sub-Investigator: Tonson-LaTour Aude, MD         
Sub-Investigator: Roy Hélène, BSc         
Sponsors and Collaborators
St. Justine's Hospital
Canadian Association of Emergency Physicians

Responsible Party: Jocelyn Gravel, MD, MSc, FRCPC, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02738229     History of Changes
Other Study ID Numbers: Valtrex for HGS
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Herpetic
Mouth Diseases
Stomatognathic Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents