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Sponsors and Collaborators: |
Johns Hopkins University Thrasher Research Fund |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00352612 |
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.
Condition | Intervention | Phase |
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Staphylococcal Infection Abscess Staphylococcal Skin Infection Folliculitis |
Drug: clindamycin Drug: cephalexin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Cephalexin Versus Clindamycin in the Empiric, Outpatient Treatment of Suspected Staphylococcal Cutaneous Infections in the Era of Community-Acquired Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) |
Estimated Enrollment: | 200 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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, 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.
Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aaron E Chen, MD | 410-955-6143 | achen33@jhmi.edu |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Aaron E Chen, MD 410-955-6143 achen33@jhmi.edu | |
Principal Investigator: Aaron E Chen, MD |
Principal Investigator: | Aaron E Chen, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Aaron Chen ) |
Study ID Numbers: | NA_00003301 |
Study First Received: | July 13, 2006 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00352612 History of Changes |
Health Authority: | United States: Institutional Review Board |
clinical trial randomized blinded controlled |
Bacterial Infections Clindamycin Skin Diseases Clindamycin-2-phosphate Cephalexin Staphylococcal Skin Infections Anti-Bacterial Agents |
Staphylococcal Infections Skin Diseases, Infectious Gram-Positive Bacterial Infections Methicillin Abscess Skin Diseases, Bacterial Folliculitis |
Hair Diseases Bacterial Infections Anti-Infective Agents Communicable Diseases Clindamycin Molecular Mechanisms of Pharmacological Action Clindamycin-2-phosphate Skin Diseases Cephalexin Enzyme Inhibitors Staphylococcal Skin Infections |
Infection Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Staphylococcal Infections Skin Diseases, Infectious Gram-Positive Bacterial Infections Therapeutic Uses Skin Diseases, Bacterial Folliculitis |