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

• ClinicalTrials.gov Identifier: NCT00352612
• Recruitment Status: Completed
• First Posted: July 14, 2006
• Results First Posted: May 13, 2013
• Last Update Posted: May 13, 2013
• Sponsor: Aaron Chen
• Collaborators: Thrasher Research Fund; Johns Hopkins University
• Information provided by (Responsible Party): Aaron Chen, Johns Hopkins University

Tracking Information

• First Submitted Date: July 13, 2006
• First Posted Date: July 14, 2006
• Results First Submitted Date: April 10, 2012
• Results First Posted Date: May 13, 2013
• Last Update Posted Date: May 13, 2013
• Study Start Date: September 2006
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2013)

Clinical Improvement at the 48-72 Hour Clinical Follow-up [ Time Frame: 48-72 hour clinical follow-up ]

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.

• Original Primary Outcome Measures (submitted: July 13, 2006): Clinical Improvement at the 48-72 Hour Clinical Follow-up
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: July 13, 2006)

• Clinical improvement at 7 days
• Time to clinical improvement
• Time to resolution of disease
• Treatment failures
• Need for subsequent hospitalization
• Need for subsequent procedure

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
• 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)
• Brief 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment

Condition

• Staphylococcal Infection
• Abscess
• Staphylococcal Skin Infection
• Folliculitis

Intervention

• 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

Study Arms

• Placebo Comparator: cephalexin
  Intervention: Drug: cephalexin
• Active Comparator: clindamycin
  Intervention: Drug: clindamycin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2006): 200
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00352612
• Other Study ID Numbers: NA_00003301
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Aaron Chen, Johns Hopkins University
• Study Sponsor: Aaron Chen

Collaborators

• Thrasher Research Fund
• Johns Hopkins University

Investigators

• Principal Investigator: Aaron E Chen, MD; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: April 2013