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临床试验/NCT06380647
NCT06380647已完成不适用

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

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Number of participants with positive Tzanck smear

研究概览

简要总结

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

详细描述

Materials and Methods Study design: Randomised control trial. Setting: Pediatric burn unit Mayo hospital Lahore Duration: 1st October 2019 to 30th September 2020. Data collection procedure: All the patients were managed with intravenous fluids, antibiotics, antipyretics and hydrocolloid dressing as per ward routine management protocol along with prophylactic acyclovir and placebo. On the zero day of admission, after parents provided informed consent, patients were randomly assigned to one of two groups using a computer-generated table. Group A patients were given intra venous acyclovir divided into three doses for 7 to 14 days during their stay. Group B patients were given 15% intravenous Hypertonic sodium chloride divided into three doses as placebo for 7 to 14 days, so that parents could be blinded to group allocation. Patients were observed for developing signs of eczema Herpeticum and Tzanck smear was done every 10th day and first follow up at outpatient department after 7days of discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

parents were blinded to group allocation

入排标准

年龄范围
1 Month 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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

干预措施: Intravenous Acyclovir (Drug)

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

干预措施: Intravenous Acyclovir (Drug)

结局指标

主要结局

Number of participants with positive Tzanck smear

时间窗: 1 year

Prophylactic acyclovir was compared with placebo regarding preventing eczema herpeticum prophylactically

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Sharif

PROFESSOR

King Edward Medical University

研究点 (1)

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