Use of Corticosteroids in Children With Cellulitis
Primary Purpose
Cellulitis
Status
Terminated
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Dexamethasone
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Cellulitis focused on measuring Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious, Corticosteroids, Glucocorticoids, Dexamethasone
Eligibility Criteria
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
Sites / Locations
- Hospital General de NIños Pedro de Elizalde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CORTICOSTEROID
NORMAL SALINE
Arm Description
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
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
Outcomes
Primary Outcome Measures
Length of stay
Secondary Outcome Measures
Fever duration
Change in erythema size
Need to change antibiotic treatment
Abscessation or spontaneous drainage
Full Information
NCT ID
NCT02087527
First Posted
February 19, 2014
Last Updated
March 9, 2017
Sponsor
Hospital General de Niños Pedro de Elizalde
1. Study Identification
Unique Protocol Identification Number
NCT02087527
Brief Title
Use of Corticosteroids in Children With Cellulitis
Official Title
Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Calculated sample size not achieved
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis
Keywords
Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious, Corticosteroids, Glucocorticoids, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CORTICOSTEROID
Arm Type
Experimental
Arm Description
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
Arm Title
NORMAL SALINE
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
ClNa 0.9%
Intervention Description
IV normal saline every 6 hours for 48 hours
Primary Outcome Measure Information:
Title
Length of stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Fever duration
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Change in erythema size
Time Frame
Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Title
Need to change antibiotic treatment
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Abscessation or spontaneous drainage
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano G Gigliotti, MD
Organizational Affiliation
Hospital General de Niños Pedro de Elizalde
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General de NIños Pedro de Elizalde
City
Buenos Aires
State/Province
CF
ZIP/Postal Code
C1270AAN
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9360253
Citation
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.
Results Reference
background
PubMed Identifier
1727879
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. doi: 10.1093/infdis/165.1.1. No abstract available.
Results Reference
background
PubMed Identifier
8477768
Citation
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.
Results Reference
background
PubMed Identifier
6387668
Citation
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.
Results Reference
background
PubMed Identifier
11319363
Citation
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.
Results Reference
background
PubMed Identifier
20556757
Citation
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.
Results Reference
background
PubMed Identifier
23622565
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. Epub 2013 Apr 24.
Results Reference
background
PubMed Identifier
33908631
Citation
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.
Results Reference
derived
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Use of Corticosteroids in Children With Cellulitis
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