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Trial record 45 of 236 for:    clindamycin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00352612
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Collaborators:
Thrasher Research Fund
Johns Hopkins University
Information provided by (Responsible Party):
Aaron Chen, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 13, 2006
First Posted Date  ICMJE July 14, 2006
Results First Submitted Date  ICMJE April 10, 2012
Results First Posted Date  ICMJE May 13, 2013
Last Update Posted Date May 13, 2013
Study Start Date  ICMJE September 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
Clinical Improvement at the 48-72 Hour Clinical Follow-up [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2006)
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 Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2006)
  • Clinical improvement at 7 days
  • Time to clinical improvement
  • Time to resolution of disease
  • Treatment failures
  • Need for subsequent hospitalization
  • Need for subsequent procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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-associated 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Staphylococcal Infection
  • Abscess
  • Staphylococcal Skin Infection
  • Folliculitis
Intervention  ICMJE
  • Drug: clindamycin
    clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
  • Drug: cephalexin
    cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
    Other Name: keflex
Study Arms  ICMJE
  • Placebo Comparator: cephalexin
    Intervention: Drug: cephalexin
  • Active Comparator: clindamycin
    Intervention: Drug: clindamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2006)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00352612
Other Study ID Numbers  ICMJE NA_00003301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aaron Chen, Johns Hopkins University
Study Sponsor  ICMJE Aaron Chen
Collaborators  ICMJE
  • Thrasher Research Fund
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Aaron E Chen, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP