Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

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ClinicalTrials.gov Identifier: NCT00867789

Recruitment Status : Terminated (Slow enrollment due to subjects not meeting inclusion/exclusion criteria)

First Posted : March 24, 2009

Results First Posted : January 26, 2021

Last Update Posted : January 26, 2021

Sponsor:

Collaborator:

Blue Cross Blue Shield

Information provided by (Responsible Party):

Children's Mercy Hospital Kansas City

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Abscess	Drug: Trimethoprim-sulfamethoxazole Drug: Sugar pill	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
Actual Study Start Date :	March 2009
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Trimethoprim-sulfamethaxazole 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) Other Name: Bactrim
Placebo Comparator: Sugar pill 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.

Outcome Measures

Primary Outcome Measures :

Health Outcomes After Use With Trimethoprim-sulfamethaxazole [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	3 Months to 17 Years (Child)
Sexes Eligible for Study:	All
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867789

Locations

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United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Blue Cross Blue Shield

Investigators

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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.

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.

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

Burney RE. Incision and drainage procedures: soft tissue abscesses in the emergency service. Emerg Med Clin North Am. 1986 Aug;4(3):527-42.

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.

Kaplan SL. Treatment of community-associated methicillin-resistant Staphylococcus aureus infections. Pediatr Infect Dis J. 2005 May;24(5):457-8. Review.

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.

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Responsible Party:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00867789
Other Study ID Numbers:	0810-162
First Posted:	March 24, 2009 Key Record Dates
Results First Posted:	January 26, 2021
Last Update Posted:	January 26, 2021
Last Verified:	January 2021

Keywords provided by Children's Mercy Hospital Kansas City:


abscess outcomes antibiotics incision and drainage skin abscess

Additional relevant MeSH terms:

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Abscess Emergencies Disease Attributes Pathologic Processes Suppuration Infection Inflammation Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Sulfamethoxazole Anti-Infective Agents, Urinary Anti-Infective Agents	Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Bacterial Agents

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