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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02087527
Other study ID # HGNPE-128-2013
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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