Herpes Simplex Virus InfectionNCT04713423
Oral and Perioral Herpes Simplex Virus Infection Type I in a Five-month-old Infant: A Case Report
An observational study of Herpes Simplex Virus Infection, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
Trial summary
A five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Herpes Simplex Virus Infection
- What is being tested?
- Diagnosis and treatment of the case
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 19 Oct 2017to 19 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a case report study
Who may be able to join
- Five-months-old infants or younger
Who cannot join
- Six-months-old infants or older
Trial locations and contacts
1 site in 1 country.
About this study
A five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles.
Read the detailed description
The investigators present the case of a five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles. The investigators discuss the pathophysiology of primary herpes simplex virus infection and the effect of maternal antibodies on the infant's immune system. In addition, the investigators explain the diagnosis, management, and prognosis of herpes simplex virus infection in young infants.
- Conditions
- Herpes Simplex Virus Infection
- Being tested
- Diagnosis and treatment of the case
- Keywords
- Herpetic gingivostomatitis, Herpes simplex virus, Perioral lesions, Infants, Case report, Herpes simplex virus type 1, Oral lesions
- Medical subject headings
- Herpes Simplex, Stomatitis, Herpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health condition
Number of tests were performed and different drugs were administered
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start19 Oct 2017
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwag Yagoub Aloyouny, Princess Nourah Bint Abdulrahman University
- Investigators
- Ashwag Y Aloyouny, Principal investigator, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713423
- Sponsor's protocol ID
- PrincessNBAU
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Perioral Herpes Simplex Virus Infection Type I in a Five-month-old Infant: A Case Report
- ClinicalTrials.gov ID
- NCT04713423
- Acronym / sponsor ID
- PrincessNBAU
- Conditions
- Herpes Simplex Virus Infection
- Keywords
- Herpetic gingivostomatitis, Herpes simplex virus, Perioral lesions, Infants, Case report, Herpes simplex virus type 1, Oral lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles.
Detailed description
The investigators present the case of a five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles. The investigators discuss the pathophysiology of primary herpes simplex virus infection and the effect of maternal antibodies on the infant's immune system. In addition, the investigators explain the diagnosis, management, and prognosis of herpes simplex virus infection in young infants.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a case report study
Key inclusion criteria (1 listed)
- Five-months-old infants or younger
Key exclusion criteria (1 listed)
- Six-months-old infants or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis and treatment of the caseThe 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. | Diagnostic test | – |
Primary outcome
Health condition
Time frame: one week
Number of tests were performed and different drugs were administered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashwag Y Aloyouny principal investigator
Princess Nourah Bint Abdulrahman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex Virus Infection, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health condition (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.