Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
Condition: Staphylococcal Infection; Abscess; Staphylococcal Skin Infection; Folliculitis
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Infections; Staphylococcal Skin Infections; Folliculitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to help define the role of antibiotics in the treatment of
      pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus
      aureus (CA-MRSA). The investigators 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.
    

Detailed description: 
      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, trimethoprim-sulfamethoxazole (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 name(s): clindamycin; cephalexin
Intervention type(s): Drug; Drug
Intervention description(s): clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days; cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
Other intervention name(s): keflex
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: clinical trial; randomized; blinded; controlled