NCT04713423

Brief Summary

A five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

January 13, 2021

Last Update Submit

January 14, 2021

Conditions

Herpes Simplex Virus Infection

Keywords

Herpetic gingivostomatitisHerpes simplex virusPerioral lesionsInfantsCase reportHerpes simplex virus type 1Oral lesions

Outcome Measures

Primary Outcomes (1)

  • Health condition

    Number of tests were performed and different drugs were administered

    one week

Interventions

Diagnosis and treatment of the caseDIAGNOSTIC_TEST

The infant was transferred to a hospital for better management of her infection. She was immediately started on intravenous acyclovir (20 mg/kg/6 h/5 d) while acetaminophen suppositories (80 mg/8 h/5 d) were given to lower her body temperature. In addition, other palliative drugs, such as diphenhydramine syrup (12.5 mg/5 mL, 2.5 mL orally) once-a-night for five days, were given to ease the effort of drinking and to aid in achieving good sleep. Upon completion of five days of therapy, the patient showed complete recovery and was subsequently discharged from the hospital free from symptoms.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a case report study

You may qualify if:

  • Five-months-old infants or younger

You may not qualify if:

  • Six-months-old infants or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Nourah Bint Abdulrahman University

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Herpes SimplexStomatitis, Herpetic

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesStomatitisMouth DiseasesStomatognathic Diseases

Study Officials

  • Ashwag Y Aloyouny

    Princess Nourah Bint Abdulrahman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior registrar of Oral Medicine

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 19, 2021

Study Start

October 19, 2017

Primary Completion

October 19, 2017

Study Completion

October 19, 2017

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

SA(1)