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Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

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ClinicalTrials.gov Identifier: NCT00730028
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Staphylococcal Infection
Interventions: Drug: Trimethoprim-sulfamethoxazole
Other: Placebo
Drug: Clindamycin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission were recruited across 6 sites from communities with an anticipated prevalence of community-associated MRSA. Participants were enrolled between April 13, 2009 and January 13, 2015

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cellulitis or Larger Abscess - Clindamycin Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Cellulitis or Larger Abscess - TMP-SMX Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Limited Abscess - Clindamycin Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Limited Abscess - TMP-SMX Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Limited Abscess - Placebo Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.

Participant Flow:   Overall Study
    Cellulitis or Larger Abscess - Clindamycin   Cellulitis or Larger Abscess - TMP-SMX   Limited Abscess - Clindamycin   Limited Abscess - TMP-SMX   Limited Abscess - Placebo
STARTED   264   260   266   263   257 
COMPLETED   204   194   221   207   175 
NOT COMPLETED   60   66   45   56   82 
Adverse Event                23                26                16                20                43 
Lost to Follow-up                13                26                22                26                25 
Protocol Violation                6                1                1                2                0 
Withdrawal by Subject                9                5                4                5                9 
Physician Decision                3                3                2                3                2 
Treatment Failure                5                5                0                0                1 
Randomization Error                1                0                0                0                2 



  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.
All participants enrolled in the protocol are included in the baseline analysis population.

Reporting Groups
  Description
Cellulitis or Larger Abscess - Clindamycin Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Cellulitis or Larger Abscess - TMP-SMX Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Limited Abscess – Clindamycin Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Limited Abscess - TMP-SMX Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Limited Abscess – Placebo Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Total Total of all reporting groups

Baseline Measures
   Cellulitis or Larger Abscess - Clindamycin   Cellulitis or Larger Abscess - TMP-SMX   Limited Abscess – Clindamycin   Limited Abscess - TMP-SMX   Limited Abscess – Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 264   260   266   263   257   1310 
Age 
[Units: Participants]
 		           
<=18 years   81   74   101   91   89   436 
Between 18 and 65 years   181   184   164   169   166   864 
>=65 years   2   2   1   3   2   10 
Age 
[Units: Years]
Mean (Standard Deviation) 		 26.8  (17.2)   27.5  (16.9)   24.8  (17.8)   25.6  (18.1)   26.2  (18.7)   27.1  (17.0) 
Gender 
[Units: Participants]
 		           
Female   129   121   126   111   101   588 
Male   135   139   140   152   156   722 
Region of Enrollment 
[Units: Participants]
 		           
United States   264   260   266   263   257   1310 


  Outcome Measures

1.  Primary:   Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.   [ Time Frame: Test of cure (TOC) (7-10 days after completion of therapy) ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.   [ Time Frame: Test of cure (TOC) (7-10 days after completion of therapy) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants Reporting Adverse Events.   [ Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants Reporting Adverse Events That Are Treatment Limiting.   [ Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU) ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.   [ Time Frame: EOT visit within 48 hours of completion of therapy ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.   [ Time Frame: EOT visit within 48 hours of completion of therapy ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.   [ Time Frame: OMFU visit ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.   [ Time Frame: OMFU visit ]
  Show Outcome Measure 8


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Henry F. Chambers, MD
Organization: San Francisco General Hospital, UCSF
phone: (415) 206 - 5437
e-mail: hchambers@medsfgh.ucsf.edu


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00730028     History of Changes
Other Study ID Numbers: 07-0051
UCSF CA-MRSA
First Submitted: August 7, 2008
First Posted: August 8, 2008
Results First Submitted: February 18, 2016
Results First Posted: March 17, 2016
Last Update Posted: March 17, 2016