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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Staphylococcal Infection; Abscess; Staphylococcal Skin Infection; Folliculitis	Drug: clindamycin; Drug: cephalexin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• 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)
• Study Start Date: September 2006
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Aaron Chen, MD, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00352612
• Other Study ID Numbers: NA_00003301
• First Posted: July 14, 2006
• Results First Posted: May 13, 2013
• Last Update Posted: May 13, 2013
• Last Verified: April 2013

Keywords provided by Aaron Chen, Johns Hopkins University:

clinical trial; randomized; blinded; controlled

Additional relevant MeSH terms:

Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Infections; Staphylococcal Skin Infections; Folliculitis; Disease Attributes; Pathologic Processes; Suppuration; Inflammation; Connective Tissue Diseases; Skin Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Bacterial; Hair Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action