Clinical trial NCT02087527: Use of Corticosteroids in Children With Cellulitis
Official title: Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cellulitis
Keywords: Cellulitis
Soft Tissue Infections
Skin Diseases, Infectious
Corticosteroids
Glucocorticoids
Dexamethasone
Lead sponsor: Hospital General de Niños Pedro de Elizalde
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Fever duration
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Change in erythema size
timeFrame: Measured at admission and after 48 hours (at the end of corticosteroids treatment)
measure: Need to change antibiotic treatment
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Abscessation or spontaneous drainage
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de NIños Pedro de Elizalde
state: CF
Study officials:
affiliation: Hospital General de Niños Pedro de Elizalde
name: Emiliano G Gigliotti, MD
role: STUDY_DIRECTOR
References:
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citation: Pushker N, Tejwani LK, Bajaj MS, Khurana S, Velpandian T, Chandra M. Role of oral corticosteroids in orbital cellulitis. Am J Ophthalmol. 2013 Jul;156(1):178-183.e1. doi: 10.1016/j.ajo.2013.01.031. Epub 2013 Apr 24.
citation: Kornelsen E, Mahant S, Parkin P, Ren LY, Reginald YA, Shah SS, Gill PJ. Corticosteroids for periorbital and orbital cellulitis. Cochrane Database Syst Rev. 2021 Apr 28;4(4):CD013535. doi: 10.1002/14651858.CD013535.pub2.