Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352612
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2006-07-13
Brief Title:
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
Sponsor:
Aaron Chen
Organization:
Johns Hopkins University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None