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

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Johns Hopkins University
Information provided by (Responsible Party):
Aaron Chen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00352612
First received: July 13, 2006
Last updated: April 1, 2013
Last verified: April 2013
Results First Received: April 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Staphylococcal Infection
Abscess
Staphylococcal Skin Infection
Folliculitis
Interventions: Drug: clindamycin
Drug: cephalexin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cephalexin patients who received cephalexin
Clindamycin those who received clindamycin

Participant Flow:   Overall Study
    Cephalexin     Clindamycin  
STARTED     100     100  
COMPLETED     100     100  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group 1 cephalexin arm
Group 2 clindamycin arm
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  100     100     200  
Age  
[units: participants]
     
<=18 years     100     100     200  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     55     60     115  
Male     45     40     85  



  Outcome Measures

1.  Primary:   Clinical Improvement at the 48-72 Hour Clinical Follow-up   [ Time Frame: 48-72 hour clinical follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Aaron Chen
Organization: Johns Hopkins University
phone: 4109556143
e-mail: achen33@jhmi.edu


No publications provided


Responsible Party: Aaron Chen, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00352612     History of Changes
Other Study ID Numbers: NA_00003301
Study First Received: July 13, 2006
Results First Received: April 10, 2012
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board