Cellulitis Clinical Trial
Official title:
Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial
Verified date | March 2017 |
Source | Hospital General de Niños Pedro de Elizalde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital General de NIños Pedro de Elizalde | Buenos Aires | CF |
Lead Sponsor | Collaborator |
---|---|
Hospital General de Niños Pedro de Elizalde |
Argentina,
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
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 |
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