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Phase 4 N=200 Randomized Double-blind Treatment

Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections

Staphylococcal Infection · Abscess · Staphylococcal Skin Infection · Folliculitis

Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Clinical Improvement at the 48-72 Hour Clinical Follow-up — 94; 97 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
clindamycin (Drug); cephalexin (Drug)
Age
Pediatric, Adult · 0+ yrs
Sex
All
Sponsor
Aaron Chen
Primary completion
May 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Clinical Improvement at the 48-72 Hour Clinical Follow-up
94; 97

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00352612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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