Abscess Clinical Trial
Official title:
Comparison of Cephalexin Versus Clindamycin in the Empiric, Outpatient Treatment of Suspected Staphylococcal Cutaneous Infections in the Era of Community-associated 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 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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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