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

Primary Purpose

Staphylococcal Infection, Abscess, Staphylococcal Skin Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
clindamycin
cephalexin
Sponsored by
Aaron Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Infection focused on measuring clinical trial, randomized, blinded, controlled

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

cephalexin

clindamycin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2006
Last Updated
April 1, 2013
Sponsor
Aaron Chen
Collaborators
Thrasher Research Fund, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00352612
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aaron Chen
Collaborators
Thrasher Research Fund, Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infection, Abscess, Staphylococcal Skin Infection, Folliculitis
Keywords
clinical trial, randomized, blinded, controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cephalexin
Arm Type
Placebo Comparator
Arm Title
clindamycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
clindamycin
Intervention Description
clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
Intervention Type
Drug
Intervention Name(s)
cephalexin
Other Intervention Name(s)
keflex
Intervention Description
cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
Primary Outcome Measure Information:
Title
Clinical Improvement at the 48-72 Hour Clinical Follow-up
Description
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.
Time Frame
48-72 hour clinical follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron E Chen, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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