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NCT Number: NCT02738229

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

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.

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Key information

Conditions

Herpetic Gingivostomatitis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Mouth Diseases Stomatitis Stomatitis, Herpetic Stomatognathic Diseases Virus Diseases

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valacyclovir

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Canadian Association of Emergency Physicians

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2016
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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