NCT00893048

Brief Summary

The prevalence of cellulitis in society is very high, as much as 3% of visits to Emergency Departments are for the treatment of this disease. The treatment of cellulitis varies depending on the severity. Low severity cases are treated with pain control and antibiotics by mouth and high severity are treated with antibiotics intravenously and pain control. The investigator's hypothesis is to see if the addition of steroids, which are known to decrease inflammation, will decrease the length of the disease process. If so, it will decrease the length of stay if IV antibiotics are needed, it will decrease duration of days out of work and decrease the overall pain control required and therefore patient satisfaction.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

January 15, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2010

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

May 1, 2009

Last Update Submit

July 21, 2017

Conditions

CellulitisErysipelas

Keywords

prednisonecellulitiserysipelassteroidsoral

Outcome Measures

Primary Outcomes (1)

  • Time to cellulitis resolving

    48 hours after initiation of treatment

Secondary Outcomes (1)

  • Length of stay

    after treatment completed

Study Arms (2)

Prednisone

EXPERIMENTAL

Use of prednisone to decrease LOS and overall treatment time of cellulitis

Drug: Prednisone

Placebo

EXPERIMENTAL
Drug: Placebo Oral Tablet

Interventions

PrednisoneDRUG

Prednisone, 60 mg, one time at time of diagnosis

Also known as: sterapred, sterapred DS
Prednisone
Placebo Oral TabletDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • signs/symptoms of cellulitis

You may not qualify if:

  • steroid use in last 2 weeks
  • hx of adrenal insufficiency
  • suspicion for dvt or abcess
  • systemic signs of sepsis
  • ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CellulitisErysipelas

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSkin Diseases, BacterialSkin Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Scott Goldstein, DO

    Penn State

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 5, 2009

Study Start

January 15, 2010

Primary Completion

August 31, 2010

Study Completion

August 31, 2010

Last Updated

July 25, 2017

Record last verified: 2017-07