Use of Corticosteroids in Children With Cellulitis

Hospital General de Niños Pedro de Elizalde

Status: Terminated

Conditions: Cellulitis

Treatments: Drug: Dexamethasone; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02087527

HGNPE-128-2013

Details and patient eligibility

About

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.

Full description

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%.

Enrollment: 19 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

CORTICOSTEROID

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

NORMAL SALINE

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline