Use of Corticosteroids in Children With Cellulitis

Cellulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02087527
• Other study ID #: HGNPE-128-2013
• Status: Terminated
• Phase: N/A
• First received: February 19, 2014
• Last updated: March 9, 2017
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis

Intervention

Drug:
• Dexamethasone
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
• Normal Saline
IV normal saline every 6 hours for 48 hours

Locations

Country	Name	City	State
Argentina	Hospital General de NIños Pedro de Elizalde	Buenos Aires	CF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (7)

Bergkvist PI, Sjöbeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82. — View Citation

Fritz KA, Weston WL. Systemic glucocorticosteroid therapy of skin disease in children. Pediatr Dermatol. 1984 Jan;1(3):236-45. Review. — View Citation

Jaussaud R, Kaeppler E, Strady C, Beguinot I, Waldner A, Rémy G. [Should NSAID/corticoids be considered when treating erysipelas?]. Ann Dermatol Venereol. 2001 Mar;128(3 Pt 2):348-51. Review. French. — View Citation

Kilburn SA, Featherstone P, Higgins B, Brindle R. Interventions for cellulitis and erysipelas. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD004299. doi: 10.1002/14651858.CD004299.pub2. Review. — View Citation

McGowan JE Jr, Chesney PJ, Crossley KB, LaForce FM. Guidelines for the use of systemic glucocorticosteroids in the management of selected infections. Working Group on Steroid Use, Antimicrobial Agents Committee, Infectious Diseases Society of America. J Infect Dis. 1992 Jan;165(1):1-13. — View 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. — View Citation

Thompson J. Role of glucocorticosteroids in the treatment of infectious diseases. Eur J Clin Microbiol Infect Dis. 1993;12 Suppl 1:S68-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay		participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Fever duration		participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Change in erythema size		Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Secondary	Need to change antibiotic treatment		participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Abscessation or spontaneous drainage		participants will be followed for the duration of hospital stay, an expected average of 5 days