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
  Purpose

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.


Condition Intervention Phase
Staphylococcal Infection
Abscess
Staphylococcal Skin Infection
Folliculitis
Drug: clindamycin
Drug: cephalexin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Enrollment: 200
Study Start Date: September 2006
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: cephalexin Drug: cephalexin
cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
Other Name: keflex
Active Comparator: clindamycin Drug: clindamycin
clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352612

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Aaron Chen
Thrasher Research Fund
Johns Hopkins University
Investigators
Principal Investigator: Aaron E Chen, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Aaron Chen, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00352612     History of Changes
Other Study ID Numbers: NA_00003301
Study First Received: July 13, 2006
Results First Received: April 10, 2012
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
clinical trial
randomized
blinded
controlled

Additional relevant MeSH terms:
Communicable Diseases
Folliculitis
Infection
Skin Diseases, Infectious
Staphylococcal Infections
Staphylococcal Skin Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Hair Diseases
Skin Diseases
Skin Diseases, Bacterial
Cephalexin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014