Official Title: “Comparison of Cephalexin Versus Clindamycin in the Empiric, Outpatient Treatment of Suspected Staphylococcal Cutaneous Infections in the Era of Community-Acquired Methicillin-Resistant Staphylococcus Aureus (CA-MRSA)”

The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by CA-MRSA. We hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is most often susceptible.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Community-associated methicillin resistant Staphylococcus Aureus (CA-MRSA) infections have increased significantly over the past decade. Nearly every major region of the country has reported infections with this organism, with some areas reporting a prevalence as high as 80%. Epidemiologic evidence points to the emergence of a new strain of MRSA within the community, with unique genetic and clinical characteristics that differentiate it from traditional hospital-associated MRSA (HA-MRSA). Unlike HA-MRSA, these CA-MRSA are often susceptible in vitro to multiple antibiotic classes (other than penicillins and cephalosporins), and often cause significant, deep-seated abscesses in healthy individuals without any known risk factors for healthcare contact. Prior to awareness of this disease, many clinicians were using penicillin and cephalosporin antibiotics for empiric treatment of cutaneous abscesses, yet widespread treatment failures in the face of increasing CA-MRSA infections did NOT occur. During a one-year retrospective study in pediatric patients at our institution, we found that nearly 50% of CA-MRSA abscesses were treated with "inappropriate" antibiotics by susceptibility profiles without any significant adverse outcomes. Many clinicians are now confronted with the dilemma of whether to change empiric antibiotic therapy to other classes to which CA-MRSA would be expected to be susceptible; the most common choices including clindamycin, TMP-SMX, or vancomycin. Unfortunately, each of these antibiotics has problems of its own in terms of increased cost, poor palatability of pediatric liquid formulation, poorer side effect profile, or necessity of IV infusion, and at this time the optimal, empiric antibiotic treatment for presumed CA-MRSA skin and soft tissue infections is unclear.

The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by CA-MRSA. We hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is most often susceptible.

Intervention(s) in this Clinical Trial

• Drug: clindamycin
  • clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
• Drug: cephalexin
  • cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days

Primary Measures

• Clinical improvement at the 48-72 hour clinical follow-up
  • Time Frame: 48-72 hour clinical follow-up
    Safety Issue?: No

Secondary Measures

• Clinical improvement at 7 days
  • Time Frame: 7 days
    Safety Issue?: No
• Time to clinical improvement
  • Time Frame: unknown
    Safety Issue?: No
• Time to resolution of disease
  • Time Frame: unknown
    Safety Issue?: No
• Treatment failures
  • Time Frame: unknown
    Safety Issue?: No
• Need for subsequent hospitalization
  • Time Frame: unknown
    Safety Issue?: No
• Need for subsequent procedure
  • Time Frame: unknown
    Safety Issue?: No

Inclusion Criteria:

• Children between the ages of 6 months and 18 years of age (inclusive)
• Suspected purulent staphylococcal skin or soft tissue infection
• No hospitalization within the previous 14 days
• Must have reliable means of follow-up contact (e.g. working phone)
• Outpatient management in the judgement of treating physician

Exclusion Criteria:

• Hospitalization on initial visit
• Voluntary withdrawal by the treating physician in order to dictate the antibiotic being used
• Patients with a history of hypersensitivity to or intolerance of cephalexin (or other beta lactams) or clindamycin.
• Patients with altered immunity (inherited or acquired)
• Patients with skin infections related to surgical wounds or hardware.
• Patients currently on antibiotic therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Johns Hopkins University

Overall Clinical Trial Officials and Contacts

Aaron E Chen, MD Principal Investigator Johns Hopkins University  

Overall Contact: Aaron E Chen, MD 410-955-6143 achen33@jhmi.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00352612

Study ID Number: NA_00003301

ClinicalTrials.gov Identifier: NCT00352612

Health Authority: United States: Institutional Review Board

Expert Summary of Recommendations for management of MRSA in the community