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. Identifier: NCT00352612
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Thrasher Research Fund
Johns Hopkins University
Information provided by (Responsible Party):
Aaron Chen, Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions: Staphylococcal Infection
Staphylococcal Skin Infection
Interventions: Drug: clindamycin
Drug: cephalexin

  Participant Flow

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
Cephalexin patients who received cephalexin
Clindamycin those who received clindamycin

Participant Flow:   Overall Study
    Cephalexin   Clindamycin
STARTED   100   100 
COMPLETED   100   100 

  Baseline Characteristics

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
Group 1 cephalexin arm
Group 2 clindamycin arm
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   100   200 
[Units: Participants]
<=18 years   100   100   200 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[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

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

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

Responsible Party: Aaron Chen, Johns Hopkins University Identifier: NCT00352612     History of Changes
Other Study ID Numbers: NA_00003301
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: April 10, 2012
Results First Posted: May 13, 2013
Last Update Posted: May 13, 2013