Trial record 3 of 334 for: Open Studies | "Prednisone"

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Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 by Albert Einstein Healthcare Network

Sponsor:

Information provided by (Responsible Party):

Scott Goldstein, DO, Albert Einstein Healthcare Network

ClinicalTrials.gov Identifier:

NCT01671423

First received: August 14, 2012

Last updated: January 30, 2015

Last verified: January 2015

History of Changes

Purpose

Cellulitis is the medical term for an infection of the skin, with symptoms including redness, swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by the body's immune system responding to the infection. Standard care for cellulitis is using antibiotics to destroy the infection, but the inflammation can persist and cause a great deal of pain. The hypothesis of this study is that adding a single dose of an oral steroid (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and speed recovery. This hypothesis will be examined by recruiting a group of patients with cellulitis, and randomizing them to two sub-groups: one group will receive a dose of prednisone, while the other group will receive a placebo. Neither group will know what they received unless there is a problem. These subjects will be followed up at the 48 hour mark and the 7 day mark, and will have their results compared.

Condition	Intervention
Cellulitis	Drug: Prednisone Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis Steroids

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:

Change in VAS for pain - day 1 to 48 hours [ Time Frame: Assessed once at day 1 and then once during the 48 hour follow-up ] [ Designated as safety issue: No ]
Difference between the level of pain as measured by a Visual Analog Scale measured once at day 1 and once during the 48 hour follow-up visit.

Secondary Outcome Measures:

Amount of pain medication - day 1 to 48 hours [ Time Frame: Assessed once during the 48 hour follow-up ] [ Designated as safety issue: No ]
Amount of pain medication the subject needed to use between day 1 and the 48 hour follow-up
Amount of pain medication - day 1 to 7 days [ Time Frame: Assessed once during the 7 day follow-up ] [ Designated as safety issue: No ]
Total amount of pain medication used between day 1 and the 7 day follow-up call.
Amount of pain medication - 48 hours to 7 days [ Time Frame: Assessed at the 48 hour follow-up and at the 7 day follow-up ] [ Designated as safety issue: No ]
Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.
Additional Medical Assistance Post-Randomization [ Time Frame: Assessed continuously from day 1 to the day 7 follow-up call ] [ Designated as safety issue: No ]
Need for additional medical intervention to treat the current episode of cellulitis.
Disposition Trend [ Time Frame: Assessed once during day 1 ] [ Designated as safety issue: No ]
Disposition of the subject at the end of the initial visit on day 1 to home or to the observation unit
Adverse Events [ Time Frame: Assessed continuously from day 1 to day 7 follow-up ] [ Designated as safety issue: Yes ]
Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)
Change in erythema size - day 1 to 48 hours [ Time Frame: Assessed once at day 1 and once during the 48 hour follow-up visit ] [ Designated as safety issue: No ]
Difference between the measured amount of erythema during day 1 and during the 48 hour follow-up visit


Estimated Enrollment:	100
Study Start Date:	August 2012
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Prednisone In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.	Drug: Prednisone See "Prednisone" arm description Other Names: Prednisone Deltasone Prednicot Sterapred
Placebo Comparator: Placebo In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.	Drug: Placebo See "Placebo" arm description Other Names: Sugar Pill Inactive Drug Control

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 to 70 years
Current episode of cellulitis
1. Erythema greater than 5 centimeters in any dimension
2. Pain, swelling, warmth, and tenderness in the area without elevated borders
Dispositioned for discharge from the Emergency Department or Observation
Able to consent

Exclusion Criteria:

Steroid use in the past 2 weeks
History of adrenal insufficiency
Any infection treated with antibiotics in the past 2 weeks
Allergy to:
1. Steroids
2. Acetaminophen
3. Trimethoprim-Sulphamethoxazole (TMP/SMX), Cephalexin, and Clindamycin (must be allergic to all three for exclusion)
4. Oxycodone and Hydrocodone (must be allergic to both for exclusion)
If subject is going to the Observation unit, allergy to:
1. Clindamycin and Vancomycin (must be allergic to both for exclusion)
2. Morphine and Hydromorphone (must be allergic to both for exclusion)
Suspicion or presence of abscess
Suspicion or presence of deep vein thrombosis
Suspicion or presence of severe sepsis, as defined by:
1. Sepsis
2. Hypotension (systolic pressure < 90 mmHg or reduction of 40 mmHg from baseline)
3. Failure of single end organ
Suspicion or presence of septic shock, as defined by:
1. Severe sepsis
2. Hypotension that is refractory to fluid management
3. Failure or more than one end organ
Crepitus
Change in mentation
Tachycardia greater than 120 beats per minute
Fever greater than or equal to 39 degrees Celsius
Hospital admission
Under 18 years of age, or over 70 years of age
Pregnancy or breast feeding
Police custody or prisoner
Cognitive impairment
Inability to consent
Nursing home residents

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671423

Contacts


Contact: Kathia Damiron	215-456-6623	DamironK@einstein.edu
Contact: Scott Goldstein, DO	215-456-6679	Goldste@einstein.edu

Locations


United States, Pennsylvania
Albert Einstein Medical Center	Recruiting
Philadephia, Pennsylvania, United States, 19141
Principal Investigator: Scott Goldstein, DO
Sub-Investigator: Milciades A. Mirre-Gonzalez
Sub-Investigator: Abdullah Khalid
Sub-Investigator: Kathia Damiron

Sponsors and Collaborators

Albert Einstein Healthcare Network

Investigators


Principal Investigator:	Scott Goldstein, DO	Albert Einstein Healthcare Network

More Information

Publications:

Bergkvist PI, Sjöbeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82.

Kiderman A, Yaphe J, Bregman J, Zemel T, Furst AL. Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice. Br J Gen Pract. 2005 Mar;55(512):218-21.

Qi D, Pulinilkunnil T, An D, Ghosh S, Abrahani A, Pospisilik JA, Brownsey R, Wambolt R, Allard M, Rodrigues B. Single-dose dexamethasone induces whole-body insulin resistance and alters both cardiac fatty acid and carbohydrate metabolism. Diabetes. 2004 Jul;53(7):1790-7.

Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9.

Yen MT, Yen KG. Effect of corticosteroids in the acute management of pediatric orbital cellulitis with subperiosteal abscess. Ophthal Plast Reconstr Surg. 2005 Sep;21(5):363-6; discussion 366-7.


Responsible Party:	Scott Goldstein, DO, Attending Physician, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:	NCT01671423 History of Changes
Other Study ID Numbers:	HN 4372
Study First Received:	August 14, 2012
Last Updated:	January 30, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Albert Einstein Healthcare Network:


Cellulitis Skin infection Prednisone Steroid Anti-inflammatory

Additional relevant MeSH terms:


Prednisone Cellulitis Connective Tissue Diseases Infection Inflammation Pathologic Processes Skin Diseases, Infectious Suppuration Anti-Inflammatory Agents	Antineoplastic Agents Antineoplastic Agents, Hormonal Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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