An interventional study of Dexamethasone and Normal Saline in Cellulitis, sponsored by Hospital General de Niños Pedro de Elizalde. Terminated at 1 site in Argentina. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-13.
Sponsored by Hospital General de Niños Pedro de Elizalde · Not applicable, Interventional, and Treatment
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.
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%.
147 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 19 is below the median of 157 across 118 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →Hospital General de Niños Pedro de Elizalde is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
Also known as: Decadron
IV normal saline every 6 hours for 48 hours
Also known as: ClNa 0.9%
Length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Fever duration
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Change in erythema size
Time frame: Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Need to change antibiotic treatment
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Abscessation or spontaneous drainage
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Plan to share: Undecided
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Hospital General de Niños Pedro de Elizalde