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

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Johns Hopkins University
Information provided by (Responsible Party):
Aaron Chen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00352612
First received: July 13, 2006
Last updated: April 1, 2013
Last verified: April 2013

July 13, 2006
April 1, 2013
September 2006
May 2009   (final data collection date for primary outcome measure)
Clinical Improvement at the 48-72 Hour Clinical Follow-up [ Time Frame: 48-72 hour clinical follow-up ] [ Designated as safety issue: No ]
Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.
Clinical improvement at the 48-72 hour clinical follow-up
Complete list of historical versions of study NCT00352612 on ClinicalTrials.gov Archive Site
Not Provided
  • Clinical improvement at 7 days
  • Time to clinical improvement
  • Time to resolution of disease
  • Treatment failures
  • Need for subsequent hospitalization
  • Need for subsequent procedure
Not Provided
Not Provided
 
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Staphylococcal Infection
  • Abscess
  • Staphylococcal Skin Infection
  • Folliculitis
  • 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
    Other Name: keflex
  • Placebo Comparator: cephalexin
    Intervention: Drug: cephalexin
  • Active Comparator: clindamycin
    Intervention: Drug: clindamycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00352612
NA_00003301
Yes
Aaron Chen, Johns Hopkins University
Aaron Chen
  • Thrasher Research Fund
  • Johns Hopkins University
Principal Investigator: Aaron E Chen, MD Johns Hopkins University
Johns Hopkins University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP