Use of Corticosteroids in Children With Cellulitis

Not Applicable

Terminated

• Conditions: Cellulitis
• Interventions: Drug: Normal Saline; Drug: Dexamethasone

• Registration Number: NCT02087527
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

Brief Summary

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

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%.

Study Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Study Start: 2014-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Children Aged 1 month to 18 years
• Hospitalized due to cellulitis
• Patients who have given their written informed consent to participate

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NORMAL SALINE	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
CORTICOSTEROID	Dexamethasone	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

Primary Outcome Measures

Name	Time	Method
Length of stay	participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital General de NIños Pedro de Elizalde; 🇦🇷 Buenos Aires, CF, Argentina