Use of Corticosteroids in Children With Cellulitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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%.

Official Title
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Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial

Conditions
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Cellulitis

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Aged 1 month to 18 years Hospitalized due to cellulitis Patients who have given their written informed consent to participate Exclusion Criteria: Skin chronic diseases Immunodeficiency (primary or acquired) Chronic use of systemic corticosteroids Sepsis 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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORTICOSTEROID<br>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 | Drug: Dexamethasone<br>* IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours<br>* Other names: Decadron;|
| Placebo Comparator: NORMAL SALINE<br>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 | Drug: Normal Saline<br>* IV normal saline every 6 hours for 48 hours<br>* Other names: ClNa 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | participants will be followed for the duration of hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious, Corticosteroids, Glucocorticoids, Dexamethasone