Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns

NCT06380647 | Completed DMC

• 1 other identifier: 0004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals. Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients

Conditions

Herpes Virus Infection

Keywords

Eczema herpeticum; pediatric burns; Acyclovir; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of participants with positive Tzanck smear

  Prophylactic acyclovir was compared with placebo regarding preventing eczema herpeticum prophylactically

  1 year

Study Arms (2)

Group A(32 patients)

EXPERIMENTAL

Group A patients were given intra venous acyclovir at dosage of 5-10 mg/kg/day into three doses for 7-14 days during their stay.Giant smear testing was done from suspected lesion on burn area to confirm viral infection

Drug: Intravenous Acyclovir

Group B (32 patients)

PLACEBO COMPARATOR

Group B patients were given intravenous normal saline 5-10 mg/kg into three doses as placebo for 7 to 14 days,Giant smear testing was done from suspected lesion on burn area to confirm viral infection

Drug: Intravenous Acyclovir

Interventions

Intravenous Acyclovir DRUG

Patients were observed for developing signs of eczema herpeticum and Tzanck smear was done every 10th day and first follow up at OPD after 7days of discharge following ward management protocol. If prophylactic acyclovir was efficacious then no eczema herpeticum developed. Patients who develop eczema herpeticum were isolated and were treated with injection acyclovir 15 to 30 mg/kg/day into three divided doses for 10 to 14 days.

Group A(32 patients); Group B (32 patients)

Eligibility Criteria

• Age: 1 Month - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Patients having previous history of skin disease.
• Patients having any Comorbidity e.g. Psoriasis, asthma, atopic dermatitis and conjunctivitis.
• Immunocompromised patients.
• Patients on steroids or chemotherapy.
• Patients already having eczema Herpeticum and positive baseline Tzanck smear

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

department of pediatric surgery King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Herpesviridae Infections; Kaposi Varicelliform Eruption

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Herpes Simplex; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Muhammad Sharif

  King edward Medical University/Mayo Hospital Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: parents were blinded to group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%.

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 24, 2024
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)