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

NCT ID: NCT00352612

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-08-31

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.

Conditions

Staphylococcal Infection; Abscess; Staphylococcal Skin Infection; Folliculitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cephalexin

Group Type: PLACEBO_COMPARATOR

cephalexin

Intervention Type: DRUG

cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days

clindamycin

Group Type: ACTIVE_COMPARATOR

clindamycin

Intervention Type: DRUG

clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days

Interventions

clindamycin

clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days

Intervention Type: DRUG

cephalexin

cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days

Intervention Type: DRUG

Other Intervention Names

keflex

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Aaron Chen

OTHER

Sponsor Role: lead

Responsible Party

Aaron Chen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aaron E Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00003301

Identifier Type: -

Identifier Source: org_study_id