Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess

NCT01498744 | Terminated Results

• 1 other identifier: IRB # 2010-14118
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.

Conditions

Abscess Soft Tissue; Methicillin-resistant Staphylococcus Aureus (MRSA) Infection; Skin Abscess

Keywords

Skin and Soft Tissue Abscess; Methicillin-resistant Staphylococcus aureus (MRSA); Incision and Drainage; Clindamycin; Trimethoprim-sulfamethoxazole; Skin Infection

Outcome Measures

Primary Outcomes (1)

• Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.

  At office visit 10-14 days post operation

Secondary Outcomes (3)

• Additional Skin and Soft Tissue Infections in Patient

  Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op

• Additional Skin or Soft Tissue Infections in Household Contacts

  Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op

• Complication to Antibiotic Regime

  Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op

Study Arms (2)

5 days postoperative antibiotic

EXPERIMENTAL

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Drug: Oral Clindamycin

1 day postoperative antibiotic

EXPERIMENTAL

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Drug: Oral Clindamycin

Interventions

Oral Clindamycin DRUG

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole \[bactrim\] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

1 day postoperative antibiotic; 5 days postoperative antibiotic

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.

You may not qualify if:

• Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.
• Children with surgical site infections will be excluded.
• Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.
• Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.
• Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.
• Patients allergic or intolerant to both bactrim and clindamycin will be excluded.
• Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements) will be excluded.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann and Robert H Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Infections; Surgical Wound; Cellulitis

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Limitations and Caveats

Inadequate enrollment numbers leading to early termination of study.

Results Point of Contact

• Title: Katherine A Barsness
• Organization: Ann and Robert H. Lurie Children's Hospital of Chicago

kbarsness@luriechildrens.org

3122274210

Study Officials

• Katherine A Barsness, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Surgery

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 23, 2011
• Study Start: February 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 25, 2016
• Results First Posted: February 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)