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

• ClinicalTrials.gov Identifier: NCT00867789
• Recruitment Status: Terminated
• First Posted: March 24, 2009
• Results First Posted: January 26, 2021
• Last Update Posted: January 26, 2021
• Sponsor: Children's Mercy Hospital Kansas City
• Collaborator: Blue Cross Blue Shield
• Information provided by (Responsible Party): Children's Mercy Hospital Kansas City

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Abscess
• Interventions: Drug: Trimethoprim-sulfamethoxazole; Drug: Sugar pill
• Enrollment: 140

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Trimethoprim-sulfamethaxazole	Sugar Pill
Arm/Group Description	Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Incision and drainage of the abscess and treatment with oral placebo (100 patients) 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.
Period Title: Overall Study
Started	70	70
Completed	68	70
Not Completed	2	0

Baseline Characteristics

Arm/Group Title		Trimethoprim-sulfamethaxazole	Sugar Pill	Total
Arm/Group Description		Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Incision and drainage of the abscess and treatment with oral placebo (100 patients) 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.	Total of all reporting groups
Overall Number of Baseline Participants		70	70	140
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	70 participants	70 participants	140 participants
	<=18 years	70 100.0%	70 100.0%	140 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	70 participants	70 participants	140 participants
	Female	38 54.3%	40 57.1%	78 55.7%
	Male	32 45.7%	30 42.9%	62 44.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	70 participants	70 participants	140 participants
		70	70	140

Outcome Measures

1. Primary Outcome

Title	Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Description	[Not Specified]
Time Frame	two years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trimethoprim-sulfamethaxazole	Sugar Pill
Arm/Group Description:	Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Incision and drainage of the abscess and treatment with oral placebo (100 patients) 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.
Overall Number of Participants Analyzed	70	70
Measure Type: Number; Unit of Measure: Percentage of outcomes assessed
	0	0

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Trimethoprim-sulfamethaxazole	Sugar Pill
Arm/Group Description	Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Incision and drainage of the abscess and treatment with oral placebo (100 patients) 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.
All-Cause Mortality
	Trimethoprim-sulfamethaxazole	Sugar Pill
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Trimethoprim-sulfamethaxazole	Sugar Pill
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/70 (0.00%)	0/70 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Trimethoprim-sulfamethaxazole	Sugar Pill
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/70 (0.00%)	0/70 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Joan Giovanni
• Organization: Children's Mercy Hospital
• Phone: 8162343430
• EMail: gegiovanni@cmh.edu

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.

• Responsible Party: Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT00867789
• Other Study ID Numbers: 0810-162
• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Results First Submitted: August 25, 2020
• Results First Posted: January 26, 2021
• Last Update Posted: January 26, 2021