Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2014-06-30
2016-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CORTICOSTEROID
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
Dexamethasone
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
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
Normal Saline
IV normal saline every 6 hours for 48 hours
Interventions
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Dexamethasone
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
Normal Saline
IV normal saline every 6 hours for 48 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hospitalized due to cellulitis
* Patients who have given their written informed consent to participate
Exclusion Criteria
* 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
1 Month
18 Years
ALL
No
Sponsors
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Hospital General de Niños Pedro de Elizalde
OTHER
Responsible Party
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Principal Investigators
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Emiliano G Gigliotti, MD
Role: STUDY_DIRECTOR
Hospital General de Niños Pedro de Elizalde
Locations
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Hospital General de NIños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina
Countries
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References
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Bergkvist PI, Sjobeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82. doi: 10.3109/00365549709011834.
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. doi: 10.1093/infdis/165.1.1. No abstract available.
Thompson J. Role of glucocorticosteroids in the treatment of infectious diseases. Eur J Clin Microbiol Infect Dis. 1993;12 Suppl 1:S68-72. doi: 10.1007/BF02389882.
Fritz KA, Weston WL. Systemic glucocorticosteroid therapy of skin disease in children. Pediatr Dermatol. 1984 Jan;1(3):236-45. doi: 10.1111/j.1525-1470.1984.tb01123.x.
Jaussaud R, Kaeppler E, Strady C, Beguinot I, Waldner A, Remy G. [Should NSAID/corticoids be considered when treating erysipelas?]. Ann Dermatol Venereol. 2001 Mar;128(3 Pt 2):348-51. French.
Kilburn SA, Featherstone P, Higgins B, Brindle R. Interventions for cellulitis and erysipelas. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD004299. doi: 10.1002/14651858.CD004299.pub2.
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.
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.
Other Identifiers
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HGNPE-128-2013
Identifier Type: -
Identifier Source: org_study_id
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