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

NCT00867789 | Terminated Results

• 1 other identifier: 0810-162
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Abscess

Keywords

abscess; outcomes; antibiotics; incision and drainage; skin abscess

Outcome Measures

Primary Outcomes (1)

• Health Outcomes After Use With Trimethoprim-sulfamethaxazole

  two years

Study Arms (2)

Trimethoprim-sulfamethaxazole

EXPERIMENTAL

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Drug: Trimethoprim-sulfamethoxazole

Sugar pill

PLACEBO COMPARATOR

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Drug: Sugar pill

Interventions

Trimethoprim-sulfamethoxazole DRUG

10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)

Also known as: Bactrim

Trimethoprim-sulfamethaxazole

Sugar pill DRUG

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.

Sugar pill

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Blue Cross Blue Shield: collaborator

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (18)

• 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. doi: 10.3201/eid1211.060190.

  PMID: 17283622 BACKGROUND

• Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32. doi: 10.1016/0736-4679(85)90077-0.

  PMID: 4093575 BACKGROUND

• Meislin HW, McGehee MD, Rosen P. Management and microbiology of cutaneous abscesses. JACEP. 1978 May;7(5):186-91. doi: 10.1016/s0361-1124(78)80097-5.

  PMID: 349218 BACKGROUND

• Macfie J, Harvey J. The treatment of acute superficial abscesses: a prospective clinical trial. Br J Surg. 1977 Apr;64(4):264-6. doi: 10.1002/bjs.1800640410.

  PMID: 322789 BACKGROUND

• 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.

  PMID: 3720656 BACKGROUND

• Llera JL, Levy RC, Staneck JL. Cutaneous abscesses: natural history and management in an outpatient facility. J Emerg Med. 1984;1(6):489-93. doi: 10.1016/0736-4679(84)90002-7.

  PMID: 6444142 BACKGROUND

• Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.

  PMID: 3880635 BACKGROUND

• 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. doi: 10.1097/00006454-200206000-00010.

  PMID: 12182377 BACKGROUND

• 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. doi: 10.1097/00006454-199911000-00012.

  PMID: 10571437 BACKGROUND

• 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. doi: 10.1016/j.annemergmed.2004.10.011.

  PMID: 15726056 BACKGROUND

• 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. doi: 10.1097/01.inf.0000151107.29132.70.

  PMID: 15750454 BACKGROUND

• 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. doi: 10.1097/00006454-200109000-00007.

  PMID: 11734764 BACKGROUND

• 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. doi: 10.1097/00006454-200210000-00005.

  PMID: 12394811 BACKGROUND

• 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. doi: 10.1001/archpedi.159.10.980.

  PMID: 16203945 BACKGROUND

• Kaplan SL. Treatment of community-associated methicillin-resistant Staphylococcus aureus infections. Pediatr Infect Dis J. 2005 May;24(5):457-8. doi: 10.1097/01.inf.0000164162.00163.9d. No abstract available.

  PMID: 15876948 BACKGROUND

• 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. doi: 10.1542/peds.2004-2300.

  PMID: 15741366 BACKGROUND

• 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. doi: 10.1001/jama.298.15.1763.

  PMID: 17940231 BACKGROUND

• 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. doi: 10.1097/01.inf.0000109288.06912.21.

  PMID: 14872177 BACKGROUND

MeSH Terms

Conditions

Abscess; Surgical Wound

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Sugars

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Carbohydrates

Results Point of Contact

• Title: Dr. Joan Giovanni
• Organization: Children's Mercy Hospital

gegiovanni@cmh.edu

8162343430

Study Officials

• Joan E Giovanni, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Locations

US (1)