Use of Corticosteroids in Children With Cellulitis

March 9, 2017 updated by: Hospital General de Niños Pedro de Elizalde

Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • CF
      • Buenos Aires, CF, Argentina, C1270AAN
        • Hospital General de Niños Pedro de Elizalde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Dexamethasone
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
Other Names:
  • Decadron
Placebo Comparator: 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
Drug: Normal Saline
IV normal saline every 6 hours for 48 hours
Other Names:
  • ClNa 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Fever duration
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
participants will be followed for the duration of hospital stay, an expected average of 5 days
Change in erythema size
Time Frame: Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Need to change antibiotic treatment
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
participants will be followed for the duration of hospital stay, an expected average of 5 days
Abscessation or spontaneous drainage
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
participants will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Niños Pedro de Elizalde

Investigators

  • Study Director: Emiliano G Gigliotti, MD, Hospital General de Niños Pedro de Elizalde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNPE-128-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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