Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department - Full Text View

Sponsor:	Children's Mercy Hospital Kansas City
Collaborator:	Blue Cross Blue Shield
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00867789

Purpose

The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.

Condition	Intervention
Abscess	Drug: Trimethoprim-sulfamethoxazole Drug: Sugar pill

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Official Title:	Trimethoprim-Sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:

The objective of this study is to compare clinical indicators of abscess resolution for two different treatment methods: 1) incision and drainage plus placebo (I&D/P) and 2) incision and drainage plus trimethoprim-sulfamethoxazole (TMP-SMX) (I&D/T-S). [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of medication adverse effect profiles between the groups, comparison of outcomes between MRSA isolates versus other pathogens between the groups, and analysis of interrater reliability of physical exam findings for a subgroup of patients. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Trimethoprim-sulfamethaxazole: Experimental Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)	Drug: Trimethoprim-sulfamethoxazole 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
Sugar pill: Placebo Comparator Incision and drainage of the abscess and treatment with oral placebo (100 patients)	Drug: Sugar pill 10mg/kg/day divided twice daily for ten days Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 3 months to 17 years
Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
Diameter of the abscess less than 5cm as measured by the treating physician

Exclusion Criteria:

Fever (>38.50 C)
Signs of systemic illness or ill-appearing, as determined by the treating physician
Admission to the hospital following treatment in the Emergency Department
Known sulfa allergy
Immunocompromised patients
Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
Previous antibiotic use (for any reason) in the past seven days
Non-English speaking patients and families

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867789

Contacts

Contact: Joan E Giovanni, MD	816-234-3665	gegiovanni@cmh.edu
Contact: Shirlee Rusk, BSN, CCRC	816-234-3665

Locations

United States, Missouri
Children's Mercy Hospitals and Clinics	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Joan E Giovanni, MD 816-234-3665 gegiovanni@cmh.edu
Contact: Shirlee Rusk, BSN, CCRC 816-234-3665

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Blue Cross Blue Shield

Investigators

Principal Investigator:

Joan E Giovanni, MD

Children's Mercy Hospital Kansas City

More Information

Publications:

McCaig LF, McDonald LC, Mandal S, Jernigan DB. Staphylococcus aureus-associated skin and soft tissue infections in ambulatory care. Emerg Infect Dis. 2006 Nov;12(11):1715-23.

Macfie J, Harvey J. The treatment of acute superficial abscesses: a prospective clinical trial. Br J Surg. 1977 Apr;64(4):264-6.

Llera JL, Levy RC, Staneck JL. Cutaneous abscesses: natural history and management in an outpatient facility. J Emerg Med. 1984;1(6):489-93.

Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9.

Frank AL, Marcinak JF, Mangat PD, Tjhio JT, Kelkar S, Schreckenberger PC, Quinn JP. Clindamycin treatment of methicillin-resistant Staphylococcus aureus infections in children. Pediatr Infect Dis J. 2002 Jun;21(6):530-4.

Frank AL, Marcinak JF, Mangat PD, Schreckenberger PC. Community-acquired and clindamycin-susceptible methicillin-resistant Staphylococcus aureus in children. Pediatr Infect Dis J. 1999 Nov;18(11):993-1000.

Frazee BW, Lynn J, Charlebois ED, Lambert L, Lowery D, Perdreau-Remington F. High prevalence of methicillin-resistant Staphylococcus aureus in emergency department skin and soft tissue infections. Ann Emerg Med. 2005 Mar;45(3):311-20.

Mishaan AM, Mason EO Jr, Martinez-Aguilar G, Hammerman W, Propst JJ, Lupski JR, Stankiewicz P, Kaplan SL, Hulten K. Emergence of a predominant clone of community-acquired Staphylococcus aureus among children in Houston, Texas. Pediatr Infect Dis J. 2005 Mar;24(3):201-6.

Fergie JE, Purcell K. Community-acquired methicillin-resistant Staphylococcus aureus infections in south Texas children. Pediatr Infect Dis J. 2001 Sep;20(9):860-3.

Sattler CA, Mason EO Jr, Kaplan SL. Prospective comparison of risk factors and demographic and clinical characteristics of community-acquired, methicillin-resistant versus methicillin-susceptible Staphylococcus aureus infection in children. Pediatr Infect Dis J. 2002 Oct;21(10):910-7.

Purcell K, Fergie J. Epidemic of community-acquired methicillin-resistant Staphylococcus aureus infections: a 14-year study at Driscoll Children's Hospital. Arch Pediatr Adolesc Med. 2005 Oct;159(10):980-5.

Gonzalez BE, Martinez-Aguilar G, Hulten KG, Hammerman WA, Coss-Bu J, Avalos-Mishaan A, Mason EO Jr, Kaplan SL. Severe Staphylococcal sepsis in adolescents in the era of community-acquired methicillin-resistant Staphylococcus aureus. Pediatrics. 2005 Mar;115(3):642-8.

Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71.

Lee MC, Rios AM, Aten MF, Mejias A, Cavuoti D, McCracken GH Jr, Hardy RD. Management and outcome of children with skin and soft tissue abscesses caused by community-acquired methicillin-resistant Staphylococcus aureus. Pediatr Infect Dis J. 2004 Feb;23(2):123-7.

Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32.

Meislin HW, McGehee MD, Rosen P. Management and microbiology of cutaneous abscesses. JACEP. 1978 May;7(5):186-91.

Burney RE. Incision and drainage procedures: soft tissue abscesses in the emergency service. Emerg Med Clin North Am. 1986 Aug;4(3):527-42. No abstract available.

Kaplan SL. Treatment of community-associated methicillin-resistant Staphylococcus aureus infections. Pediatr Infect Dis J. 2005 May;24(5):457-8. Review. No abstract available.

Responsible Party:	Children's Mercy Hospitals and Clinics ( Joan E. Giovanni, MD )
Study ID Numbers:	0810-162
Study First Received:	March 23, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00867789 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

abscess
outcomes
antibiotics
incision and drainage
skin abscess

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Disease Attributes
Trimethoprim
Molecular Mechanisms of Pharmacological Action
Sulfamethoxazole
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Trimethoprim-Sulfamethoxazole Combination
Folic Acid Antagonists
Renal Agents

Infection
Pharmacologic Actions
Inflammation
Antimalarials
Anti-Bacterial Agents
Antiparasitic Agents
Pathologic Processes
Abscess
Therapeutic Uses
Emergencies
Suppuration

ClinicalTrials.gov processed this record on February 08, 2010