Study Stopped
Calculated sample size not achieved
Use of Corticosteroids in Children With Cellulitis
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 13, 2017
March 1, 2017
1.8 years
February 19, 2014
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of stay
participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcomes (4)
Fever duration
participants will be followed for the duration of hospital stay, an expected average of 5 days
Change in erythema size
Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Need to change antibiotic treatment
participants will be followed for the duration of hospital stay, an expected average of 5 days
Abscessation or spontaneous drainage
participants will be followed for the duration of hospital stay, an expected average of 5 days
Study Arms (2)
CORTICOSTEROID
EXPERIMENTALIn 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
NORMAL SALINE
PLACEBO COMPARATORIn 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
Interventions
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
Eligibility Criteria
You may qualify if:
- Children Aged 1 month to 18 years
- Hospitalized due to cellulitis
- Patients who have given their written informed consent to participate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General de NIños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina
Related Publications (8)
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.
PMID: 9360253BACKGROUNDMcGowan 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.
PMID: 1727879BACKGROUNDThompson 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.
PMID: 8477768BACKGROUNDFritz 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.
PMID: 6387668BACKGROUNDJaussaud 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.
PMID: 11319363BACKGROUNDKilburn 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.
PMID: 20556757BACKGROUNDPushker 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.
PMID: 23622565BACKGROUNDKornelsen 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.
PMID: 33908631DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emiliano G Gigliotti, MD
Hospital General de Niños Pedro de Elizalde
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
March 14, 2014
Study Start
June 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 13, 2017
Record last verified: 2017-03