Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to antibiotic treatment during the first 48 hours of admission to the hospital in patients with cellulitis and its impact in the duration of the stay.
详细描述
Cellulitis is a common skin and soft tissue infection in the pediatric population.
Although most of the time treatment could be administered on an ambulatory setting , sometimes it may require hospitalization and parenteral antibiotic administration. Using corticosteroids during antibiotic treatment may reduce inflammation and length of stay.
Objective
to evaluate the efficacy of using corticosteroids as adjuvant treatment during the first 48 hours of treatment after hospitalization in patients with cellulitis.
Patients and methods: this is a double blind, randomized, controlled trial that will take place at pediatric hospital, during one year. It will include children aged 1 month to 18 years, admitted due to cellulitis. Once included in the clinical trial, the patients will be randomized to receive dexamethasone 0,6 mg/kg/day or placebo (saline solution) during the first 48 hours. Considering an average stay of 4 ± 2 days, we calculated a sample size of 124 children (62 children per group) to detect a 25% difference (1 day reduction) in the length of stay, with a power of 80% and a confidence of 95%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children Aged 1 month to 18 years
- •Hospitalized due to cellulitis
- •Patients who have given their written informed consent to participate
排除标准
- •Skin chronic diseases
- •Immunodeficiency (primary or acquired)
- •Chronic use of systemic corticosteroids
- •Varicella
- •History of adrenal insufficiency
- •Pregnancy or breast feeding
- •Uncontrolled diabetes mellitus
- •Known hypersensitivity to systemic or topical corticosteroids
- •Patient undergoing immunosuppressive therapy for another disease
- •Participation in another drug biomedical research
- •Any other contraindication for treatment with corticosteroids
研究组 & 干预措施
CORTICOSTEROID
In addition to standard care for cellulitis, subject will receive intravenous Dexamethasone (8mg/2ml) 0.15 mg/kg/dose every 6 hours for the first 48 hours
干预措施: Dexamethasone (Drug)
NORMAL SALINE
In addition to standard care for cellulitis, subject will receive normal saline solution administered intravenously using the same volume as the active drug group every 6 hours for the first 48 hours
干预措施: Normal Saline (Drug)
结局指标
主要结局
Length of stay
时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 days
次要结局
- Fever duration(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Change in erythema size(Measured at admission and after 48 hours (at the end of corticosteroids treatment))
- Need to change antibiotic treatment(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Abscessation or spontaneous drainage(participants will be followed for the duration of hospital stay, an expected average of 5 days)