CellulitisNCT02087527
Use of Corticosteroids in Children With Cellulitis
A study testing Dexamethasone and Normal Saline in people with Cellulitis, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cellulitis
- What is being tested?
- Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children Aged 1 month to 18 years
- Hospitalized due to cellulitis
- Patients who have given their written informed consent to participate
Who cannot join
- Skin chronic diseases
- Immunodeficiency (primary or acquired)
- Chronic use of systemic corticosteroids
- Sepsis
- Varicella
- History of adrenal insufficiency
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital General de NIños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., C1270AAN
About this study
Official title: 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.
Read the 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%.
- Conditions
- Cellulitis
- Being tested
- Dexamethasone, Normal Saline
- Keywords
- Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious, Corticosteroids, Glucocorticoids, Dexamethasone
- Medical subject headings
- Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
Normal SalineDrug
Also called ClNa 0.9%
IV normal saline every 6 hours for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| CORTICOSTEROID | Experimental | 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 Receives: Drug: Dexamethasone |
| NORMAL SALINE | Placebo comparator | 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 Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (4)
Fever duration
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Change in erythema size
Measured: Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Need to change antibiotic treatment
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Abscessation or spontaneous drainage
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Calculated sample size not achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emiliano G Gigliotti, MD, Study director, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087527
- Sponsor's protocol ID
- HGNPE-128-2013
- Status last verified
- Mar 2017
- First submitted
- 19 Feb 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 9360253McGowan 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.
PubMed 1727879Thompson 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.
PubMed 8477768Fritz 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.
PubMed 6387668Jaussaud 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.
PubMed 11319363Kilburn 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.
PubMed 20556757Pushker 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.
PubMed 23622565Kornelsen 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.
PubMed 33908631
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02087527
- Acronym / sponsor ID
- HGNPE-128-2013
- Conditions
- Cellulitis
- Keywords
- Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious, Corticosteroids, Glucocorticoids, Dexamethasone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Calculated sample size not achieved
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORTICOSTEROID | Experimental | Drug: DexamethasoneIn 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 comparator | Drug: Normal SalineIn 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 |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children Aged 1 month to 18 years
- Hospitalized due to cellulitis
- Patients who have given their written informed consent to participate
Key exclusion criteria (12 listed)
- Skin chronic diseases
- Immunodeficiency (primary or acquired)
- Chronic use of systemic corticosteroids
- Sepsis
- Varicella
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: DecadronIV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours | Drug | CORTICOSTEROID |
| Normal SalineAlso: ClNa 0.9%IV normal saline every 6 hours for 48 hours | Drug | NORMAL SALINE |
Primary outcome
Length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
4 secondary outcomes
Fever duration
Time frame: 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)
Need to change antibiotic treatment
Time frame: 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
Results and safety
The study was stopped early (reason given: Calculated sample size not achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Background: PubMed 9360253Bergkvist 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.
- Background: PubMed 1727879McGowan 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.
- Background: PubMed 8477768Thompson 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.
- Background: PubMed 6387668Fritz 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.
- Background: PubMed 11319363Jaussaud 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.
- Background: PubMed 20556757Kilburn 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.
- Background: PubMed 23622565Pushker 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.
- Derived from this study: PubMed 33908631Kornelsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano G Gigliotti, MD study director
Hospital General de Niños Pedro de Elizalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Normal Saline in people with Cellulitis, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Calculated sample size not achieved). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02087527, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.