Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | August 10, 2009 | ||||
Start Date ICMJE | September 2006 | ||||
Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Clinical improvement at the 48-72 hour clinical follow-up [ Time Frame: 48-72 hour clinical follow-up ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Clinical improvement at the 48-72 hour clinical follow-up | ||||
Change History | Complete list of historical versions of study NCT00352612 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections | ||||
Official Title ICMJE | 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) | ||||
Brief Summary | The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by 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. |
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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, 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 200 | ||||
Completion Date | August 2009 | ||||
Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Months to 18 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352612 | ||||
Other Study ID Numbers ICMJE | NA_00003301 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Aaron Chen, Johns Hopkins University | ||||
Study Sponsor ICMJE | Johns Hopkins University | ||||
Collaborators ICMJE | Thrasher Research Fund | ||||
Investigators ICMJE |
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Information Provided By | Johns Hopkins University | ||||
Verification Date | August 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |