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

Abscess Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352612
• Other study ID #: NA_00003301
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2006
• Last updated: April 1, 2013
• Start date: September 2006
• Est. completion date: August 2009

Study information

• Verified date: April 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Abscess
• Communicable Diseases
• Folliculitis
• Infection
• Skin Diseases, Infectious
• Staphylococcal Infection
• Staphylococcal Infections
• Staphylococcal Skin Infection
• Staphylococcal Skin Infections

Intervention

Drug:
• clindamycin
clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
• cephalexin
cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Aaron Chen	Johns Hopkins University, Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement at the 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.	48-72 hour clinical follow-up	No

External Links

•   Expert Summary of Recommendations for management of MRSA in the community