NCT02087527

Use of Corticosteroids in Children With Cellulitis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hospital General de Niños Pedro de Elizalde · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Cellulitis

Interventions

Type	Name	Description
DRUG	Dexamethasone	IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
DRUG	Normal Saline	IV normal saline every 6 hours for 48 hours

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-03-14
• Last updated: 2017-03-13

Locations

1 site across 1 country: Argentina